(30 days)
No
The summary describes a standard ophthalmic ultrasound system with improved hardware (probe frequency) for better measurement accuracy. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No.
The device is indicated for diagnostic imaging and biometric measurement of the eye, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for diagnostic imaging and biometric measurement of the eye". This includes various diagnostic applications such as visualization of the eye's interior and orbit, axial length measurement, IOL power calculation, and corneal thickness measurement.
No
The device description explicitly states it consists of a base and probes, which are hardware components. It also mentions hardware validation activities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The COMPACT TOUCH Ophthalmic Ultrasound System uses ultrasound to image and measure structures within the eye and orbit. It does not perform tests on samples taken from the body.
- Intended Use: The intended use clearly describes diagnostic imaging and biometric measurement of the eye, which are in-vivo procedures.
Therefore, while it is a diagnostic medical device, it falls under the category of in-vivo diagnostic imaging and measurement rather than in-vitro diagnostics.
N/A
Intended Use / Indications for Use
The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- Visualization of the interior of the eye and the orbit by A and B scans.
- Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation, using the Axial Length measurement.
- Measurement of corneal thickness by ultrasonic means.
Product codes
IYO, ITX
Device Description
The COMPACT TOUCH Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic
Anatomical Site
Eye, orbit
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:
- AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 Medical . electrical equipment-Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007: Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- IEC 62366-1 Medical Devices-Part 1: Application of usability engineering to medical . devices
- IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 ● Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement accuracy has been improved (from ± 0.2 mm to ± 0.115 mm)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in large blue letters. Below that is the word "ADMINISTRATION" in smaller blue letters.
March 2, 2018
Quantel Medical % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street. NW BUFFALO MN 55313
Re: K180265
Trade/Device Name: COMPACT TOUCH® Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: February 26, 2018 Received: February 27, 2018
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
COMPACT TOUCH® Ophthalmic Ultrasound System
Indications for Use (Describe)
The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- · Visualization of the interior of the eye and the orbit by A and B scans.
- · Axial Length measurement of the eve by ultrasonic means.
- · Implanted IOL power calculation, using the Axial Length measurement.
· Measurement of corneal thickness by ultrasonic means.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Page : 2/5
System: Compact Touch
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | P | (A-mode) | |||||
| P | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Musculo-skeletal | |||||||
| (Conventional) | ||||||||
| Musculo-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Cardiac | Trans-esoph (Cardiac) | |||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
P=Previously cleared in K094038
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Page : 3/5
System: Compact Touch
Transducer : 15 MHz B-scan Probe (ref model number B1)
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | N | ||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-Skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
5
Page : 4/5
System: Compact Touch
11 MHz Biometry Probe (ref model number : TP-01-b/ TP-02-las) Transducer :
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 | |||||||||
| Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) B/M | Other | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | (A-mode) | |||||||
| P | |||||||||
| Fetal | |||||||||
| Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-Skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
P=Previously cleared in K094038
6
Page : 5/5
System: Compact Touch
Transducer : Pachymetry Probe (ref model number : P1 : (20 MHz A-scan)
Intended Use : Diagnostic ultrasound imaging of the human body as follows :
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 | ||||||||
| Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) B/M | Other | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | (A-mode) | ||||||
| P | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Fetal | ||||||||
| Imaging & | ||||||||
| Other | Musculo-Skeletal (Superficial) | |||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac Adult | ||||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph (Cardiac) | ||||||||
| Cardiac | Intra-cardiac | |||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N= new indication ; P=previously cleared by FDA ; E=added under Appendix E
P=Previously cleared in K094038
7
510(k) SUMMARY
Quantel Medical COMPACT TOUCH® Ophthalmic Ultrasound System
510(k) Owner
Quantel Medical 11 rue Bois Joli CS40015 63808 Cournon D'Auvergne-Cedex France 33 04 73 745 732 Phone: Contact Person: Bruno Pagès
Submission Correspondent:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Phone: 978-207-1245
Date Prepared: February 28, 2018
Trade Name of Device
COMPACT TOUCH OPHTHALMIC ULTRASOUND SYSTEM
Common or Usual Names
Ultrasonic Pulsed Echo Imaging system Ultrasonic Diagnostic Transducer
Classification Names
Ultrasonic Pulsed Echo Imaging system; 21 C.F.R. 892.1560 Class II Product Codes: IYO
Transducer, Ultrasonic, Diagnostic; 21 C.F.R. 892.1570 Class II Product Codes: ITX
Predicate Device
Quantel Medical Compact Touch (K094038)
8
Device Description
The COMPACT TOUCH Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.
Intended Use / Indications for Use
The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including:
- . Visualization of the interior of the eye and the orbit by A and B scans.
- . Axial Length measurement of the eye by ultrasonic means.
- Implanted IOL power calculation. using the Axial Length measurement. ●
- Measurement of corneal thickness by ultrasonic means. ●
Substantial Equivalence
The COMPACT TOUCH Ophthalmic Ultrasound System described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to a legally marketed predicate device that is a Class II medical device which is the Quantel Medical COMPACT TOUCH® (K094038). The indications for use statement for the COMPACT TOUCH Ophthalmic Ultrasound System is exactly the same as the indications for use statement for the predicate device.
The COMPACT TOUCH Ophthalmic Ultrasound System and the predicate device, the previous version of the same device, are equivalent regarding technological characteristics. Both systems include diagnostic imaging with biometry and pachymetry performed with an A-Scan probe and diagnostic imaging and axial length measurements performed with a B-Scan probe. The A-scan probe used in both systems is identical with the same transducer used in both systems.
There have been minor modifications to the B-Scan probe where the transducer frequency of the B-scan probe has been increased from 10 MHz for the cleared COMPACT TOUCH® to 15 MHz for the new version. This variation of frequency does not affect the safety or performance of the device. The IEC 60601-2-37 tests have been followed in order to cover the new transducer specification (the MI value is inferior to 0.23).
All other aspects of the two systems remain identical with the exception of the following items which have been determined not to impact the safety and effectiveness:
- Physical Characteristics: revised dimensions and look of device and addition of Wi-Fi connection. Electrical safety and electromagnetic compatibility testing have been
9
performed which shows the new version of the device continues to comply with the electrical safety standards.
- -Electronic: the degree of protection against electric shock has been changed from BF to B due to the change of the power supply. The IEC 60601-1 tests have been followed in order to cover this new configuration.
- Measurement accuracy has been improved (from ± 0.2 mm to ± 0.115 mm) due to the increase of the frequency of the probe.
- General Software: the software has been revised to accommodate the other device changes listed here.
- -Documentation: an HDMI port has been added to the device.
In summary, the new version of the COMPACT TOUCH Ophthalmic Ultrasound System has the same indications for use and similar technological characteristics to the predicate device and is therefore, substantially equivalent.
Performance Data
Performance testing was conducted in order to demonstrate compliance with recognized consensus standards:
- AAMI ANSI ES60601-1:2005 + Corr. 1:2006+Corr. 2:2007+A1:2012 Medical . electrical equipment-Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2:2007: Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance-Collateral standard: Electromagnetic compatibility-Requirements and tests
- IEC 60601-1-6:2010+A1:2013 Medical electrical equipment-Part 1-6: General requirements for safety-Collateral Standard Usability
- IEC 62366-1 Medical Devices-Part 1: Application of usability engineering to medical . devices
- IEC 60601-2-37: "Ed2 + AM1 with 60601-1 (ed.3), AM1 with correc 1 & correc 2 ● Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment
Additionally, hardware and software validation activities were performed to ensure the device performed as intended and software documentation appropriate for the Moderate level of concern was provided.