(100 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): Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, ergonomic control panel with easy user interface, optimal image quality.
The provided 510(k) summary for the E-CUBE 7 Ultrasonic Pulsed Doppler Imaging System states that clinical studies were not required to support substantial equivalence to its predicate device, the E-CUBE 9 Diagnostic Ultrasound System (K120060).
Therefore, the following information regarding acceptance criteria and performance study details cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No clinical performance data is reported.
- Sample size used for the test set and the data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No experts involved in establishing ground truth for a clinical test.
- Adjudication method for the test set: No adjudication method specified as there was no clinical test set.
- 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: No MRMC study was conducted. This device is an ultrasound imaging system, not an AI-assisted diagnostic tool for reading improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was assessed for diagnosis.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No clinical ground truth was established for a performance study.
- The sample size for the training set: No training set was used for an AI/machine learning model.
- How the ground truth for the training set was established: No ground truth for a training set was established.
Summary based on the provided document:
The E-CUBE 7 was deemed substantially equivalent to its predicate device, E-CUBE 9, based on non-clinical tests and the same fundamental scientific technology.
Non-clinical tests performed include:
- Biocompatibility
- Acoustic output
- Thermal safety
- Electrical safety
- Electromagnetic safety
- Mechanical safety
The device was found to conform to applicable medical device safety standards and complies with voluntary standards. Quality management system measures applied to its development include: Medical Device Risk Management, Requirements Reviews, Design Reviews, Component Verification, Integration Review (System Verification), Performance Testing (System Verification), Safety Testing (Compliance Test), and Design Validation. Transducer materials and other patient contact materials are also stated to be biocompatible.
{0}------------------------------------------------
<12/729
510(k) E-CUBE 7
510(k) Summary
In accordance with 21CFR807.92, the following summary of information is provided;
Date June 8tt 2012
Submitter: ALPINION MEDICAL SYSTEMS Co., Ltd. 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 Person
Yuchi Chu Address: Suite 229, 10604 NE 38th Place, Kirkland, WA 98033, United States Phone: 425 949 4907 Fax: 425 949 4908 Email: ychu@alpinionus.com
E-CUBE 7 Device Trade Name:
Ultrasonic Pulsed Doppler Imaging System Common/Usual Name:
System, Imaging, Pulsed Doppler Ultrasonic · Classification Names
Ultrasonic Pulsed Doppler Imaging System, 21CFR 892.1550 90-Product Code: IYN Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Predicate Device(s):
Predicate Device(s) K120060 E-CUBE 9 Diagnostic Ultrasound System
Diagnostic Ultrasound Transducer, 21CFR 892.1570, 90-ITX
{1}------------------------------------------------
510(k) E-CUBE 7
Device Description:
E-CUBE 7 product is an ultrasound imaging system for medical diagnosis. The system platform provides optimal patient diagnosis workflow with the 18.5" wide flat panel display, 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 thyroid): Trans-rectal(TR); Trans-vaginal(TV); (breast. testes, Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
E-CUBE 7 employs the same fundamental scientific technology as Technology: its predicate device.
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests:
E-CUBE 7 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 7 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 7:
- � Medical Device Risk Management
- � Requirements Reviews
- Design Reviews �
- Component Verification ◆
- Integration Review (System Verification) �
- Performance Testing (System Verification) �
- Safety Testing (Compliance Test) ◆
- Design Validation
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, E-CUBE 7, did not require clinical studies to support substantial equivalence.
Conclusion:
Alpinion Medical Systems Co., Ltd. Considers E-CUBE 7 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.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized emblem. The emblem is a stylized image of an eagle.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 2 0 2012
Mr. Donghwan Kim QARA Manager Alpinion Medical Systems Co., Ltd. 1. 6 and 7FL. Verdi Tower, 72 Digital-ro (St) 26-gil (Rd), Guro-gu SEOUL 152-848 REPUBLIC OF KOREA
Re: K121729
Trade/Device Name: E-CUBE 7 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 20, 2012 . Received: July 20, 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 7. as described in your premarket notification:
Transducer Model Number
GI-Q L3-12 SP1-5 EN3-10 E3-10
{3}------------------------------------------------
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 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 Shahram Vaezy, PhD at (301) 796-6242.
Sincerely Yours,
Michal O'Kane for
Janine M. Morris Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: E-CUBE 7
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); Trans-rectal(TR); Trans-vaginal(TV); Musculo-skeletal(Conventional); Musculo-skeletal (Superficial); Cardiac (adult); Peripheral Vascular (PV); and Urology (including prostate).
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use_ (Part 21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
(Division Sign-Off)
Division of Radiological Devices
310k 51279
{5}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 Ultrasound System
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 | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | P | ||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | |||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | ||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | ||
| Intravascular | |||||||||
| Cardiac Adult | P | P | P | P | P | P | P | ||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Peripheral vessel | P | P | P | P | P | P | P | ||
| Urology (including prostate) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diaggostic Devices
(Division Sign-Off)
Division of Radiological Devices
K121729
QIVD
Prescription User (Per 21 CFR 801.109)
E-2
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 with C1-6 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 | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| 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) | P | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **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 |
|---|---|
| ----------------------------------------- | --------------------------- |
510
Prescription User (Per 21 CFR 801.109)
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 with L3-12 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 | P | P | P | P | P | P | P | |||
| Small Organ(breast, testes, thyroid) | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Trans-esoph. (non-Card.) | ||||||||||
| Musculo-skeletal(Conventional) | P | P | P | P | P | P | P | |||
| Musculo-skeletal(Superficial) | P | P | P | P | P | P | P | |||
| Intravascular | ||||||||||
| Cardiac Adult | ||||||||||
| Cardiac Pediatric | ||||||||||
| Intravascular (Cardiac) | ||||||||||
| Trans-esoph. (Cardiac) | ||||||||||
| Intra-cardiac | ||||||||||
| Peripheral vessel | P | P | P | P | P | P | P | |||
| Urology (including prostate) |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUEZON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitre Diagnostic Devices (IV
(Division Sign-Of)
Division of Radiological Devices
510k K1217890
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
E-4
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 with SP1-5 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 | P | P | P | P | P | P | P | ||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | P | P | P | P | P | P | P | ||
| 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 | P | P | P | P | P | P | P | ||
| 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/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In-Vitro Diagnostic De
| Prescription User (Per 21 CFR 801.109) | |
|---|---|
| ---------------------------------------- | -- |
(Division Sigh-Off)
Division of Radiological Devices
510k K121789
ALPINION MEDICAL SYSTEMS Co., Ltd.
E-5
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 with EN3-10 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 | Color | Power | Tissue | Combined* | Other** | |
| Doppler | Doppler | HarmonicImaging | (Specify) | (Specify) | |||||
| Ophthalmic | |||||||||
| Fetal | |||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ(breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal | P | P | P | P | P | P | |||
| 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) | P | P | P | P | P | P | |||
| N = new indication; P = previously cleared by FDA; E = added under appendix |
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANQTHER FAGE IF NEEDED)
510k
Concurrence of CDRH, Office of In-Vitro Digg
Prescription User (Per 21 CFR 801.109)
ALPINION MEDICAL SYSTEMS Co., Ltd.
Radiological Devices
{10}------------------------------------------------
Diagnostic Ultrasound Indications for Use Form
E-CUBE 7 with E3-10 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 | |||||||||
| Small Organ | |||||||||
| (breast, testes, thyroid) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | P | P | P | P | P | |||
| Trans-vaginal · | P | P | P | P | P | P | |||
| 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) | P | P | P | P | P | P |
N = new indication; P = previously cleared by FDA; E = added under appendix
- Combined: B/Color Doppler, B/PWD, B/Color Doppler/PWD; **Other: 3D, 4D
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
510k
Concurrence of CDRH, Office of In-Vitro Diagnostic Devices
Prescription User (Per 21 CFR 801.109)
E-7
Division Sign-Off of Radiological Devices
§ 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.