(24 days)
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE inno product is a mobile ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc. The system platform provides optimal patient diagnosis workflow with ergonomic control panel with easy user interface, optimal image quality.
The information provided describes a 510(k) premarket notification for the ALPINION MEDICAL SYSTEMS Co., Ltd. E-CUBE inno ultrasonic pulsed Doppler imaging system. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove efficacy against acceptance criteria.
Therefore, many of the requested items related to clinical studies (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set sample size, how training set ground truth was established, type of ground truth used) are not applicable in this context, as the equivalence was primarily based on non-clinical tests and a comparison of features and indications for use.
Here's the breakdown of the information that can be extracted:
Acceptance Criteria and Device Performance
The "acceptance criteria" in this context refer to demonstrating that the E-CUBE inno is substantially equivalent to its predicate device (LOGIQ i, LOGIQ e, Vivid e, specifically LOGIQ e is used for comparison in the table) in terms of indications for use, material, form factor, performance, and safety characteristics. The "reported device performance" is the comparison of these characteristics between the proposed device and the predicate.
Table of Acceptance Criteria (Substantial Equivalence Comparison) and Reported Device Performance
| Feature/Criterion (Acceptance Criteria) | Proposed E-CUBE inno Performance | Predicate LOGIQ e Performance | Discussion/Conclusion of Equivalence |
|---|---|---|---|
| Indications for Use | Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal (Conventional); Musculoskeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate). | Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal Conventional and Superficial; Cardiac (adult and pediatric); Peripheral Vascular (PV); Urology (including prostate); Intra-operative (abdominal, thoracic, PV); Neonatal Cephalic & Adult Cephalic; Trans-esophageal; Trans-rectal; Trans-vaginal (TV); and Thoracic/Pleural | The E-CUBE inno has a limited scope of indications compared to the predicate, specifically lacking: Intra-operative (abdominal, thoracic, PV); Neonatal Cephalic & Adult Cephalic; Trans-esophageal; Trans-rectal; Trans-vaginal (TV); and Thoracic/Pleural applications. The submitter states that "the individual functions of E-CUBE inno has essential performance and safety effectiveness same as LOGIQ e, even though E-CUBE inno has limited scope of the indications comparing with the predicate. Therefore, E-CUBE inno is substantially equivalent with predicate device." |
| Dimensions and Weight | Weight: approx. 7.2kg (excluding Option)Height: 83.5~415 mmWidth: 410 mmDepth: 371 mm | Weight: approx. 4.6kg (with battery)Height: 61mm/1410 mmWidth: 340mmDepth: 287mm/ 337mm with handle | Differences in dimensions and weight are noted, but these are considered cosmetic structure and component differences not impacting substantial equivalence. |
| Monitor | 15 inch LCDDisplay size: 1024 X 768Monitor tilt: More than 165 degrees | 15 inch TFT LCDDisplay size: 1024 X 768Monitor tilt: 160 degrees (maximum) | Very similar monitor specifications. |
| Electrical Power | Voltage: 24V 6.5AFrequency: 50/60HzPower: 120 VA MAX with Peripherals | Voltage: 20V 5AFrequency: 50/60HzPower: Max. 130 VA with Peripherals | Minor differences in voltage and power, but within acceptable limits for equivalence in medical devices of this type. |
| Console Design | 1 Active Probe PortIntegrated HDD (Capacity: 500G)Rear HandleOn-board Storage for Peripherals (B/W Printer, Color Printer, DVD RW)USB ports, internal ECG | 1 Active Probe PortIntegrated HDD (Capacity: 160G)Rear HandleLithium ion battery pack (Standard)On-board Storage for Peripherals (B/W Printer, Color Printer, DVD RW)USB ports, USB ECG (AHA/IEC) SupportCWD Support | The E-CUBE inno has more storage capacity (500G vs 160G), which is not considered to impact safety and effectiveness. It lacks a Lithium ion battery pack, which is deemed "not essential parts." |
| Operating Mode | B ModeM ModeColor Flow ModePower Doppler ModePulse Wave Doppler ModeContinuous Wave DopplerSRI | B ModeM ModeAnatomical M modeColor Flow ModePower Doppler ModePulse Wave Doppler ModeContinuous Wave Doppler ModeTissue Doppler ImagingSRI | The E-CUBE inno lacks Anatomical M mode and Tissue Doppler Imaging, but "E-CUBE inno includes essential operating mode for diagnosis and is Substantially Equivalent." |
| Accessories or Kits | Color printer, B/W printer, DVD-RW, Ultrasonic gel, Cidex OPA (disinfectant agents), Cidex Plus (disinfectant agents), SC1-6 Biopsy Starter kit, L3-12 Biopsy Starter kit, Patient ECG cable (AHA/IEC) | Color printer, B/W printer, DVD-RW, Footswitch, Lithium ion battery pack (Standard), Aquasonic 100 Scan Gel, Scan Ultrasound Gel, Cidex OPA (disinfectant agents), Sterile Ultrasound Probe Sheath Set, Sterile Ultrasound Cord Sheath Set, Sanitary Rectal/Vaginal Probe Cover, Sterile Combination Probe and Cord Cover Set, Sterile Ultrasound Probe Sheath Set for Wide Aperture Sector Probes, USB ECG (AHA/IEC) Support, Isolation/Docking Cart | E-CUBE inno doesn't include a lithium ion battery or Footswitch, but these are considered "not essential parts." The specific types of biopsy kits, gels, and probe sheaths differ. |
| Measurement and Calculation Functions | General (B-Mode, M-Mode, Doppler Mode); Abdomen (B-Mode, M-Mode, Doppler Mode); Small Parts (B-Mode, M-Mode, Doppler Mode); Obstetrics (B-Mode, M-Mode, Doppler Mode); Gynecology (B-Mode, M-Mode, Doppler Mode); Cardiology (B-Mode, M-Mode, Doppler Mode); Vascular (B-Mode, M-Mode, Doppler Mode); Urology (B-Mode, M-Mode, Doppler Mode); Pediatrics (B-Mode, M-Mode, Doppler Mode) | General (B-Mode, M-Mode, Doppler Mode); Abdomen (B-Mode, M-Mode, Doppler Mode); Small Parts (B-Mode, M-Mode, Doppler Mode); Obstetric (B-Mode, M-Mode, Doppler Mode); Gynecology (B-Mode, M-Mode, Doppler Mode); Cardiology (B-Mode, M-Mode, Doppler Mode); Vascular (B-Mode, M-Mode, Doppler Mode); Urology (B-Mode, M-Mode, Doppler Mode); Pediatrics (B-Mode, M-Mode, Doppler Mode) | The device offers the same categories of measurement and calculation functions across the listed clinical applications as the predicate. |
| Acoustic Output | Track 3 | Track 3 | Identical acoustic output specification. |
| Fundamental Scientific Technology | Employs the same fundamental scientific technology as its predicate device. | (Implicitly, uses ultrasonic pulsed Doppler imaging technology) | Explicitly stated as the "same fundamental scientific technology." |
Overall Conclusion of Equivalency:
The submitter concludes that the E-CUBE inno is substantially equivalent to the predicate device, despite some differences in indications for use, weight, console design components (like battery), and specific operating modes/accessories. These differences are deemed not to affect the essential performance or safety and effectiveness of the device. The primary differences are attributed to "cosmetic structure and component used only."
Study that Proves the Device Meets the Acceptance Criteria:
This submission is a 510(k) for an ultrasound imaging system. For such devices, clinical studies explicitly proving performance against pre-defined acceptance criteria (like accuracy, sensitivity, specificity for a diagnostic algorithm) are often not required if substantial equivalence to a predicate device can be demonstrated through other means.
The document explicitly states:
"The subject of this premarket submission, E-CUBE inno, did not require clinical studies to support substantial equivalence."
Instead, the demonstration of substantial equivalence relies on:
- Comparison to a Legally Marketed Predicate Device: The E-CUBE inno was compared feature-by-feature to the GE Healthcare LOGIQ e (K113690) to show that it has similar technological characteristics and indications for use.
- Summary of Non-Clinical Tests:
- Evaluations for biocompatibility (for patient contact materials/transducers).
- Acoustic output.
- Thermal, electrical, electromagnetic, and mechanical safety.
- Conformity to applicable medical device safety standards:
- NEMA UD2, UD3
- AIUM Medical Ultrasound Safety
- IEC60601-1
- IEC60601-1-2
- IEC60601-2-37
- ISO 10993-1
- Application of quality management system measures during development.
Additional Requested Information (Not Applicable or Not Provided for this type of submission):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not Applicable. No clinical test set data was provided or required for this 510(k) submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not Applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not Applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not Applicable. This is a basic ultrasound imaging system, not an AI-assisted diagnostic device, and no MRMC studies were conducted for this 510(k).
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not Applicable. This is a hardware/software system, and its performance is evaluated as a whole in comparison to a predicate, not as a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not Applicable.
- The sample size for the training set: Not Applicable. No training set for an AI algorithm was mentioned or relevant to this 510(k).
- How the ground truth for the training set was established: Not Applicable.
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JUL 26 2012
510(k) E-CUBE inno
In accordance with 21CFR807.92, the following summary of information is provided;
Jun 29" 2012 Date
ALPINION MEDICAL SYSTEMS Co., Ltd. Submitter: Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848,
Primary Contact Person
Donghwan Kim QARA Manager Address: 1, 6 and 7FL Verdi Tower, 72, Digital-ro(St) 26-gil(Rd), Guro-gu, Seoul, Republic of Korea 152-848, Phone: +82 70 7465 2068 Fax: +82 2 851 5594 Email: donghwan.kim@alpinion.com
Secondary Contact Yuchi Chu
Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, Person United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@alpinionus.com
- Device Trade Name: E-CUBE inno
Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System
Classification Names System, Imaging, Pulsed Doppler Ultrasonic
Product Code: Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
Predicate Device(s) K113690 LOGIQ i, LOGIQ e, Vivid e
Device Description: E-CUBE inno product is a mobile ultrasound imaging system for medical diagnosis. This product can be used for the applications of abdominal, obstetrics, gynecology, small parts, cardiology, vascular, etc.
The system platform provides optimal patient diagnosis workflow with ergonomic control panel with easy user interface, optimal image quality.
Indications For Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculoskeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
ALPINION MEDICAL SYSTEMS Co., Ltd.
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| Feature | ProposedE-CUBE innoALPINION MEDICAL SYSTEMS Co.,Ltd. | PredicateLOGIQ eGE Healthcare |
|---|---|---|
| 510(k)Number | K113690 | |
| Indications foruse | The device is intended for use by aqualified physician for the evaluation ofsoft tissue and blood flow in the clinicalapplications;Fetal;Abdominal,Pediatric;Small Organ (breast, testes, thyroid);Musculo-skeletal(Conventional);Musculo-skeletal (Superficial);Cardiac adult;Peripheral Vascular (PV);and Urology (including prostate). | The device is intended for use by aqualified physician for the evaluation ofsoft tissue and blood flow in the clinicalapplications:Fatal/OB;Abdominal(GYN & Urology);Pediatric;Small Organ (breast, testes, thyroid);Musculo-skeletal Conventional andSuperficial;Cardiac (adult and pediatric);Peripheral Vascular (PV);Urology (including prostate);Intra-operative (abdominal, thoracic, PV)Neonatal Cephalic &Adult Cephalic;Trans-esophageal;Trans-rectal;Trans-vaginal (TV); and Thoracic/Pleural |
| Discussion of differences●The individual functions of E-CUBE inno has essential performance and safetyeffectiveness same as LOGIQ e, even though E-CUBE inno has limited scope ofthe indications comparing with the predicate. | ||
| Dimensionsand weight | Therefore, E-CUBE inno is substantially equivalent with predicate device.Weight: approx. 7.2kg (excluding Option)Height: 83.5~415 mmWidth: 410 mmDepth: 371 mm | Weight: approx. 4.6kg(with battery)Height: 61mm/1410 mmWidth: 340mmDepth: 287mm/ 337mm with handle |
| Monitor | 15 inch LCDDisplay size: 1024 X 768Monitor tilt- More than 165 degrees | 15 inch TFT LCDDisplay size : 1024 X 768Monitor tilt- 160 degrees (maximum) |
| Electricalpower | Voltage:24V 6.5AFrequency: 50/60HzPower: 120 VA MAX with Peripherals | Voltage: 20V 5AFrequency: 50/60HzPower: Max. 130 VA with Peripherals |
| Consol design | 1 Active Probe PortIntegrated HDD (Capacity: 500G)Rear HandleOn-board Storage for Peripherals- B/W Printer, Color Printer, DVD RWUSB ports, internal ECG | 1 Active Probe PortIntegrated HDD(Capacity: 160G)Rear HandleLithium ion battery pack(Standard)On-board Storage for Peripherals- B/W Printer, Color Printer, DVD RW,USB ports, USB ECG(AHA/IEC) SupportCWD Support |
| Discussion of differences | ||
| E-CUBE inno has more storage capacity of image than Logiq e and it is not related | ||
| with the safety and effectiveness and essential performance. | ||
| E-CUBE inno doesn't include a Lithium ion battery pack but this is not essential | ||
| parts. | ||
| Operating Mode | B ModeM ModeColor Flow ModePower Doppler ModePulse Wave Doppler ModeContinuous Wave DopplerSRI | B ModeM ModeAnatomical M modeColor Flow ModePower Doppler ModePulse Wave Doppler ModeContinuous Wave Doppler ModeTissue Doppler ImagingSRI |
| Discussion of difference | ||
| E-CUBE inno includes essential operating mode for diagnosis and isSubstantially Equivalent | ||
| Labelingand/orpromotionalmaterials | Section 6 User manualSection 6A Catalog E-CUBE inno | Section 3B User manual GE Logiq eSection 3C Catalog GE Logiq e |
| Accessories orkits | Color printerB/W printerDVD-RWUltrasonic gelCidex OPA (disinfectant agents)Cidex Plus (disinfectant agents)SC1-6 Biopsy Starter kitL3-12 Biopsy Starter kitPatient ECG cable((AHA/IEC) | Color printerB/W printerDVD-RWFootswitchLithium ion battery pack(Standard)Aquasonic 100 Scan GelScan Ultrasound GelCidex OPA (disinfectant agents)Sterile Ultrasound Probe Sheath SetSterile Ultrasound Cord Sheath SetSanitary Rectal/Vaginal Probe CoverSterile Combination Probe and Cord Cover SetSterile Ultrasound Probe Sheath Set for Wide Aperture Sector ProbesUSB ECG(AHA/IEC) SupportIsolation/Docking Cart |
| Discussion of difference | ||
| E-CUBE inno doesn't include a lithium ion battery, Footswitch but this is not | ||
| essential parts. | ||
| Measurement and Calculation functions | ||
| 1. General1) B-Mode2) M-Mode3) Doppler Mode | 1. General1) B-mode2) M-Mode:3) Doppler Mode | |
| 2. Abdomen1) B-Mode2) M-Mode3) Doppler Mode | 2. Abdomen1) B-Mode2) M-Mode3) Doppler Mode | |
| 3. Small Parts1) B-Mode2) M-Mode3) Doppler Mode | 3. Small Parts1) B-Mode2) M-Mode3) Doppler Mode | |
| 4. Obstetrics1) B-Mode2) M-Mode:3) Doppler Mode | 4. Obstetric1) B-Mode:2) M-Mode:3) Doppler Mode | |
| 5. Gynecology1) B-Mode2) M-Mode:3) Doppler Mode | 5. Gynecology1) B-Mode2) M-Mode3) Doppler Mode | |
| 6. Cardiology1) B-Mode2) M-Mode3) Doppler Mode | 6. Cardiology1) B-Mode2) M-Mode3) Doppler Mode: | |
| 7. Vascular1) B-Mode2) M-Mode3) Doppler Mode | 7. Vascular1) B-Mode2) M-Mode3) Doppler Mode | |
| 8. Urology1) B-Mode2) M-Mode3) Doppler Mode | 8. Urology1) B-Mode2) M-Mode3) Doppler Mode | |
| 9. Pediatrics1) B-Mode2) M-Mode3) Doppler Mode | 9. Pediatrics1) B-Mode2) M-Mode3) Doppler Mode | |
| Acoustic output | Track 3 | Track 3 |
E-CUBE inno employs the same fundamental scientific technology Technology: as its predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. •
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ALPINION MEDICAL SYSTEMS Co., Ltd.
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The indications for use, material, form factor, performance, and safety characteristics between E-CUBE inno and the predicate device are the same except for Intra-operative (abdominal, thoracic, PV); Neonatal Cephalic &Adult Cephalic; Trans-esophageal; Trans-rectal; Trans-vaginal (TV); and Thoracic/Pleural. The primary difference is cosmetic structure and component used only. Therefore, we can claim the substantially equivalence of E-CUBE inno to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd.
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Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
E-CUBE inno has been evaluated for biocompatibility, acoustic output as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. E-CUBE inno and its application comply with voluntary standards as detailed in this premarket submission. The following quality management system measures were applied to the development of E-CUBE inno:
- NEMA UD2, UD3 �
- AIUM Medical Ultrasound Safety �
- IEC60601-1
- IEC60601-1-2 �
- IEC60601-2-37
- ISO 10993-1 �
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE inno, did not require clinical studies to support substantial equivalence.
Conclusion:
ALPINION MEDICAL SYSTEMS Co., Ltd. considers E-CUBE inno to be as safe, as effective, and performance is substantially equivalent to the predicate device.
ALPINION MEDICAL SYSTEMS Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA or the requirements will be published in guidance documents.
ALPINION MEDICAL SYSTEMS Co., Ltd.
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Appendix B - Decision Summary for Web Posting
Decision Summary, K 121937
This 510(k) was reviewed under OIVD's Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.
The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant's 510(k) summary for a summary of the information that supports this SE determination.
OIVD, 6/12/12, v1.2
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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 2 6 2012
Mr. Donghwan Kim QARA Manager Alpinion Medical Systems Co., Ltd. 1. 6 and 7 FL. Verdi Tower 72, Digital-ro (St) 26-gil (Rd), Guro-gu SEOUL 152-848 REPUBLIC OF KOREA
Re: K121937
Trade/Device Name: E-CUBE inno Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 28, 2012 Received: July 2, 2012
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the E-CUBE inno, as described in your premarket notification:
Transducer Model Number
| C1-6iSP1-5i | L3-8iL3-12i |
|---|---|
| ---------------------------------------------------------------- | ---------------------------------------------------------------- |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can
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be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Jeffrey Ballyns at (301) 796-6105.
Sincerely Yours,
hul D'O'hurn for.
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use Statement
510(k) Number (if known):
Device Name: E-CUBE inno
Indications for Use:
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications; Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV) and Urology (including prostate).
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)
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મું દિવ
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AND/OR
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K. 5121937
ALEINION MEDICAL SYSTEMS Co., Ltd.
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Diagnostic Ultrasound Indications for Use
E-CUBE inno Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Combined*(Specify) | Other**(Specify) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | |||
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | N | |
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | N | |
| Small Organ | N | N | N | N | N | N | N | ||
| (breast, testes, thyroid) | N | N | |||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | |||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | |||
| Intravascular | |||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
RIOK
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Diagnostic Ultrasound Indications for Use
E-CUBE inno with C1-6i Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | N | N | N | N | N | N | N | ||
| Abdominal | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| · Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | |||||||||
| Urology (including prostate) | N | N | N | N | N | N | N |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
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Muhd DDA
Division Sign-Off
Gotogical Devices ce Evelusion and Se Office of in Vitro
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Diagnostic Ultrasound Indications for Use
E-CUBE inno with SP1-5i Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | ||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | N | N | N | ||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | ||||||||||
| Musculo-skeletal(Superficial) | ||||||||||
| Intravascular | ||||||||||
| Cardiac Adult | N | N | N | N | N | N | N | N | ||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | ||||||||||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
E-4
{12}------------------------------------------------
Diagnostic Ultrasound Indications for Use
E-CUBE inno with L3-8i Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Combined* (Specify) | Other** (Specify) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | Color Doppler | Power Doppler | Tissue Harmonic Imaging | ||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative (Specify) | ||||||||||
| Intra-operative (Neuro) | ||||||||||
| Laparoscopic | ||||||||||
| Pediatric | N | N | N | N | N | N | N | |||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal (Conventional) | N | N | N | N | N | N | N | |||
| Musculo-skeletal (Superficial) | N | N | N | N | N | N | N | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | N | N | N | N | N | N | N | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual 8; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K121937
E-5 ·
{13}------------------------------------------------
Diagnostic Ultrasound Indications for Use E-CUBE inno with L3-12i Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| B | M | PWD | CWD | ColorDoppler | PowerDoppler | TissueHarmonicImaging | Combined*(Specify) | Other**(Specify) | |
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | N | N | N | N | N | N | N | ||
| Small Organ(breast, testes, thyroid) | N | N | N | N | N | N | N | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | N | N | N | N | N | N | N | ||
| Musculo-skeletal(Superficial) | N | N | N | N | N | N | N | ||
| Intravascular | |||||||||
| Cardiac Adult | |||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | N | N | N | N | N | N | N | ||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/M, B/PWD, B/CF, B/PD, B/CF/PWD, B/CF/M, Dual B; ** Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
Prescription User (Per 21 CFR 801.109)
| ALPINION MEDICAL SYSTEMS Co., Ltd. | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K121937 |
E-6
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.