(113 days)
Not Found
No
The summary describes a standard ultrasonic imaging and measurement system for ophthalmic use, with no mention of AI or ML 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 medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for diagnostic imaging and biometric measurement of the eye".
No
The device description explicitly states it is an "ultrasonic system" composed of a "main console" and "three probes," which are hardware components.
Based on the provided information, this device 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 QUANTEL MEDICAL Compact TOUCH Ophthalmic Ultrasound System uses ultrasound to image and measure structures within the eye and orbit. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states diagnostic imaging and biometric measurement of the eye, which are performed directly on the patient.
Therefore, this device falls under the category of medical imaging and measurement devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The QUANTEL MEDICAL 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 (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe. The Compact TOUCH system includes three ultrasonic probes. The A-scan probe (TP-01 / TP-02-las) operates at 11 MHz and has an effective diameter of 5 mm. This probe is identical to that used by the predicate, AVISO K051851. The B-scan probe operates at 10 MHz and has an active diameter of 7.5 mm. This probe is identical to that used by the predicate, AVISO K051851. The Pachymetry probe is of the A-scan type with a frequency of 20 MHz with a 1.5 mm active diameter. This probe is identical to that used by the predicate, POCKET K993674.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasonic, A scans, B scans
Anatomical Site
Eye, orbit, corneal
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)
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 met design specifications and was substantially equivalent to the predicate devices. No Clinical testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Section 5
1694038
APR 2 2 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 12-21-09 [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
Contact Information B.
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 Ophthalmic Ultrasound System
Device Common Name: Ophthalmic Ultrasound System
Classification Name: System, Imaging, Ultrasonic, Ophthalmic (per 21 CFR 892.1560)
Product Code: IYO
Panel: 86 Ophthalmic
Device Classification: Class II
D. Predicate Devices [21 CFR 807.92(a)(3)]
The Compact TOUCH uses similar technology and physical output characteristics as the following predicate devices:
K051851 Quantel Medical AVISO Ophthalmic Ultrasound System
K993674 Quantel Medical POCKET Ultrasonic Pachymeter
E. Device Description [21 CFR 807.92(a)(4)]
The Compact TOUCH is an ultrasonic system designed for ophthalmic use. It combines A and B type scans for diagnostic imaging of the eye. The system is composed of a main console controlled by a touch screen. It consists of three probes which plug into the main console; the B-scan probe, the A-scan probe, and a Pachymetry probe.
F. Device Specifications [21 CFR 807.92(a)(6)]
The Compact TOUCH system includes three ultrasonic probes. The A-scan probe (TP-01 / TP-02-las) operates at 11 MHz and has an effective diameter of 5 mm. This probe is identical to that used by the predicate, AVISO K051851. The B-scan probe operates at 10 MHz and has an active diameter of 7.5 mm. This probe is identical to that used by the predicate, AVISO K051851. The Pachymetry probe is of the A-scan type with a frequency of 20 MHz with a 1.5 mm active diameter. This probe is identical to that used by the predicate, POCKET K993674.
2
G. Indications for Use [21 CFR 807.92(a)(5)]
The QUANTEL MEDICAL 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. .
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 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 was found to be substantially equivalent to the currently cleared K051851 Quantel Medical AVISO Ophthalmic Ultrasound System and K993674 Quantel Medical POCKET Ultrasonic Pachymeter. The indications for use are similar to these previously cleared devices. The risks and benefits for the Compact TOUCH 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Michael Johnson, M.D. Medical Product Manager Quantel USA 601 Haggerty Lane BOZEMAN MT 59715
APR 2 2 2010
Re: K094038
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 and ITX Dated: March 16, 2010 Received: March 19, 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 Ophthalmic Ultrasound System, as described in your premarket notification:
Transducer Model Number
10 MHz B-Scan Probe (Ref model number: B1 Biometry Probe (Ref model number: TP-01-b/TP-02-las Pachymetrey Probe (Ref model number: P1: (20 MHz A-scan)
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/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health (CDRH) 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 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 vours.
Robert Becker, Jr. (for)
Donald St. Pierre
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
Indications for Use
510(k) Number (if known): NA______________________________________________________________________________________________________________________________________________
Device Name: ___Compact TOUCH Ophthalmic Ultrasound System
Indications for Use:
The QUANTEL MEDICAL 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. .
- Axia! Length measurement of the eye by ultrasonic means. .
- Implanted IOL power calculation, using the Axial Length measurement. ●
- Measurement of corneal thickness by ultrasonic means. .
4-1
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | (Per 21 CER 810.109) |
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K | K0940384 |
6
Page _ 2 _ of ________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): NA
Device Name: COMPACT Touch
Intended Use: The Quantel Medical COMPACT Touch is intended to be used for:
- -Visualization of the interior of the eye and the orbit by A and B-scans.
- The 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.
| CLINICAL
APPLICATION | A | B | M | PWD | CWD | COLOR
DOPPLER | POWER
(AMPLITUDE)
DOPPLER | COLOR
VELOCITY
IMAGING | COMBINED
(SPECIFY) | OTHER
(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | P | 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
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
4-2 (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use✗ (Per 21 CFR 810.109)
(Division Sign-Off Division of Radiological Device Office of In Vitro Diagnostic Device Evaluation and Safety
510K 6940638
7
Page _ 3_of_5_
510(k) Number (if known): NA
Device Name: COMPACT Touch with 10 MHz B-Scan Probe(Ref model number B1)
Intended Use: The intended use of the COMPACT Touch with the 10MHz B-scan Probe is diagnostic imaging of the eye by B scans.
| 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
N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments:
4-3
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 810.109)
Robert J. Becker
(Division Sign-Off Division of Radiological D Office of In Vita n and Safety
510K. K094038
8
Page 4 of 5_
510(k) Number (if known): NA
Device Name: Compact TOUCH with the Biometry Probe (Ref model number: TP-01-b / TP-02-las)
Intended Use: The Compact TOUCH with the Biometry Probe is intended for the Axial Length measurement of the eye by ultrasonic means. This measurement is required to make the IOL calculation for most types of cataract surgery.
| 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) | | | | | | | | | | |
| 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
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
4-4
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 810.109)
Peter M. Rockey
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K094038
9
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): NA
Device Name: Compact TOUCH with the Pachymetry Probe (Ref model number: P1 : (20 MHz A-scan))
Intended Use: The Compact TOUCH with the Pachymetry Probe is intended for the measurement of corneal thickness by ultrasonic means, which is required for some types of corneal surgery.
| 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
N= new indication; P= previously cleared by FDA; E= added under Appendix E
Additional Comments:
4-5
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
ಳ
(Per 21 CFR 810.109)
Robert M. Becker
Division of Radiologica Office of In Vitro Diagnostic Device Evalua
K094038
510K