(93 days)
No
The document describes a standard ultrasonic imaging system for ophthalmic use and does not mention any AI or ML capabilities, image processing beyond basic measurements, or the use of training/test data sets typically associated with AI/ML development.
No.
The device is strictly for diagnostic imaging and measurement, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for diagnostic imaging and measurement of the eye." The "Device Description" also mentions it "performs B type scans for diagnostic imaging of the eye."
No
The device description explicitly states the system is composed of a main console controlled by a touch screen and uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer. These are hardware components, making it a hardware-based medical device with integrated software.
Based on the provided information, the Quantel Medical COMPACT TOUCH STS is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The COMPACT TOUCH STS is an ultrasonic imaging system that performs B-scans and makes measurements inside the eye. It directly interacts with the patient's body to acquire images and data.
- Lack of Sample Analysis: The device does not analyze samples taken from the body.
Therefore, the COMPACT TOUCH STS falls under the category of a medical imaging device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
Product codes
IYO, ITX
Device Description
The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Eye
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
Laboratory testing following the guidance "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" (Sept 9, 200) was conducted to verify that the COMPACT TOUCH STS met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.
Key Metrics
Not Found
Predicate Device(s)
K060626 Sonomed Inc. VuMax Ophthalmic Ultrasound System
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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Section 5
OV - 5 2010
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR 807.87 and 807.92. Summary preparation date 08-06-10 [21 CFR 807.92(a)(1)].
Applicant Name and Address [21 CFR 807.92(a)(1)] A.
Quantel Medical S.A.
21 rue Newton
ZI Le Brezet
63039 Clermont Ferrand Cedex 2
FRANCE
Tel: +33 (0) 473 745 745
Fax: +33 (0) 473 745 700
B. Contact Information
Quantel USA
601 Haggerty Lane
Bozeman, MT 59715
Tel: 406-586-0131
Fax: 406-586-2924
Contact person: Michael Johnson M.D.
1
C. Device Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Trade Name: COMPACT TOUCH STS Ophthalmic Ultrasound System
Device Common Name: Ophthalmic Ultrasound System
Classification Name: Ultrasonic Pulsed Echo Imaging System (21 CFR 892.1560) and Diagnostic Ultrasound Transducer (21 CFR 892.1570).
Product Code: IYO and ITX, respectively
Panel: 86 Ophthalmic
Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The COMPACT TOUCH STS uses similar technology and physical output characteristics as the following predicate devices:
K060626 Sonomed Inc. VuMax Ophthalmic Ultrasound System
E. Device Description [21 CFR 807.92(a)(4)]
The COMPACT TOUCH STS is an ultrasonic system designed for ophthalmic use. It performs B type scans for diagnostic imaging of the eye. It is not intended to be used for determining the power of implanted lenses, but rather is capable of making intra-ocular measurements. The system is composed of a main console controlled by a touch screen. It uses a B-scan probe (LIN50) which is a motor driven 50 MHz transducer.
F. Device Specifications [21 CFR 807.92(a)(6)]
The COMPACT TOUCH STS system includes a B-scan ultrasonic probe. The Bscan probe operates at 50 MHz and has an active diameter of 4.5 mm.
5-2
2
Indications for Use [21 CFR 807.92(a)(5)] G.
The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
◆ Make measurements inside the eye (Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
H.
Performance Data [21 CFR 807.92(b)(2)]
Laboratory testing following the guidance "Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound systems and Transducers" (Sept 9, 200) was conducted to verify that the COMPACT TOUCH STS met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.
I. Conclusion [21 CFR 807.92(b)(3)]
Technologically, the COMPACT TOUCH STS was found to be substantially equivalent to the currently cleared K060626 Sonomed Inc. VuMax Ophthalmic Ultrasound System. The indications for use are similar to these previously cleared devices. The risks and benefits for the COMPACT TOUCH STS are argued to be comparable to the predicate devices. We believe that there are no new questions of safety or efficacy raised by the introduction of the COMPACT TOUCH STS.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 - Room 5645 Silver Spring, MD 20993-0002
Quantel Medical S.A. c/o Dr. Mike Johnson QUANTEL USA 601 Haggerty Lane BOZEMAN MT 59715
2010
Re: K102198/S001
Trade/Device Name: COMPACT ACT TOUCH STS Ophthalmic Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Il Product Code: IYO, and ITX Dated: October 1, 2010 Received: October 1 2010
Dear Dr Johnson:
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 COMPACT TOUCH STS LIN50 ultrasound probe, as described in your premarket notification:
Transducer Model Number .
LIN50 ..
4
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 at (301) 796-6242.
Sincerely yours,
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
5
Section 4
NOV - 5 2010
Indications for Use
510(k) Number (if known): not known i wi
Device Name: "COMPACT TOUCH STS" Ophthalmic Ultrasound System
Indications for Use Statement:
The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
Concurrence of CDRH, Office of Device Evaluation
510K
◆ Make measurements inside the eye ( Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
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Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
6
Diagnostic Ultrasound Indications for Use Form
Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): NA
Device Name: COMPACT TOUCH STS
Intended Use: The Quantel Medical COMPACT TOUCH STS is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
� Make measurements inside the eye ( Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | | P | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative
(specify) | | | | | | | | | | |
| Intra-operative | | | | | | | | | | |
| Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ
(Specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Trans-rectal | | | | | | | | | | |
| Trans-vaginal | | | | | | | | | | |
| Trans-urethral | | | | | | | | | | |
| Intra-luminal | | | | | | | | | | |
| Peripheral
Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-Skeletal | | | | | | | | | | |
| Other (Specify)* | | | | | | | | | | |
Mode of Operation
Additional Comments:
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | X |
| (Per 21 CFR 810.109) |
7
Diagnostic Ultrasound Indications for Use Form
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): NA
Device Name: COMPACT TOUCH STS LIN50 ultrasonic probe.
Intended Use: The Quantel Medical COMPACT TOUCH STS LIN 50 ultrasonic probe is intended to be used for diagnostic imaging and measurement of the eye including:
◆ Visualization of the interior of the eye by B scan
� Make measurements inside the eye ( Sulcus to Sulcus, Irido Cornea Angle Left, Irido Cornea Angle Right, Lens curvature and Anterior Chamber Depth).
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| CLINICAL | ||||||||||
| APPLICATION | A | B | M | PWD | CWD | COLOR | ||||
| DOPPLER | POWER | |||||||||
| (AMPLITUDE) | ||||||||||
| DOPPLER | COLOR | |||||||||
| VELOCITY | ||||||||||
| IMAGING | COMBINED | |||||||||
| (SPECIFY) | OTHER | |||||||||
| (SPECIFY) | ||||||||||
| Ophthalmic | P | |||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intra-operative | ||||||||||
| (specify) | ||||||||||
| Intra-operative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ | ||||||||||
| (Specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Trans-esophageal | ||||||||||
| Trans-rectal | ||||||||||
| Trans-vaginal | ||||||||||
| Trans-urethral | ||||||||||
| Intra-luminal | ||||||||||
| Peripheral | ||||||||||
| Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-Skeletal | ||||||||||
| Other (Specify)* |
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | X (Per 21 CFR 810.109) |