POCKET ULTRASONIC PACHYMETER

K993674 · Quantel Medical · IYO · Jul 13, 2000 · Radiology

Device Facts

• Record ID: K993674
• Device Name: POCKET ULTRASONIC PACHYMETER
• Applicant: Quantel Medical
• Product Code: IYO · Radiology
• Decision Date: Jul 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The device is intended to be used for the measurement of corneal thickness which is required for some types of corneal surgery.

Device Story

Small, hand-held ultrasonic ophthalmic pachymeter; uses pulsed ultrasound (sonar principles) to measure corneal thickness. Operator pre-plans measurement series on corneal surface; device automatically sequences measurements; presents results as thickness over eye area. Used in clinical settings by eye care professionals. Output provides quantitative corneal thickness data to assist in surgical planning and clinical decision-making. Benefits include precise corneal assessment for surgical procedures.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing, including IEC 601-1 and 601-1-2 compliance, accuracy testing, and software validation. Device technology is established and widely used in clinical practice.

Technological Characteristics

Hand-held ultrasonic pachymeter; 20 MHz A-Scan transducer (Model P1). Operates via pulsed ultrasound. Complies with IEC 601-1 and 601-1-2 standards. Software-controlled measurement sequencing.

Indications for Use

Indicated for measurement of corneal thickness in patients undergoing corneal surgery.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Sonomed 200P Ultrasonic Pachymeter (K924311)
• DGH Model 500 Pachymeter (K920906)

Submission Summary (Full Text)

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K993674
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Ouantel Medical S.A.. 510(k) Submission "Pocket" Ultrasonic Pachymeter

510(k) Summary

(1) Submitter Information

Name: Quantel Medical S.A.

Address: 89, Boulevard Etienne Clémentel 63100 Clermont-Ferrand FRANCE

Telephone Number: [phone]

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone [phone] Fax [phone]

Date Prepared: October 26, 1999

(2) Name of Device

Trade Name: "Pocket" Ultrasonic Pachymeter Common Name: Ultrasonic Pachymeter for Measurement of Corneal thickness Classification name: System, Imaging, Ultrasonic, Ophthalmic, 9801YO

(3) Equivalent legally-marketed devices.

1. Sonomed 200P Ultrasonic Pachymeter, K924311 2. DGH Model 500 Pachymeter, K920906

(4) Description

The POCKET is a small, hand-held ultrasonic Ophthalmic Pachymeter that uses the principles of sonar (pulsed ultrasound) to measure corneal thickness. The device allows the operator to pre-plan a series of measurements on the surface of the cornea, to go automatically from one to the other while making the

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K993674
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measurements, and then to present the results of the measurements as thickness over an area of the eye.

- (5) Intended Use
The device is intended to be used for the measurement of corneal thickness by The device is mich is required for some types of corneal surgery.

#### (6) Performance Data

. (a) Non-clinical tests

The POCKET has passed all tests for IEC 601-1 and 601-1-2. The unit has also had accuracy tests done by an outside laboratory.

Transducers have had output emissions done by an outside laboratory.

The Pocket software has undergone extensive validation testing.

(b) Clinical tests

Since the POCKET uses the same technology as existing devices, clinical tests are Billed in I OCREF assos and in Europe for several years and has not had reported problems.

(c) Conclusions

The Pocket pachymeter is equivalent in safety and efficacy to the legallymarketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

# JUL 1 3 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Quantel Medical S.A. c/o George H. Myers, Sc.D. Official Correspondent Medsys, Inc. 377 Route 17 South Hasbrouck Heights, NJ 07604

K993674 Re : Quantel Pocket Ultrasonic Pachymeter Regulatory Class: II/21 CFR 892.1560 Product Code: 90 IYO Dated: June 16, 2000 Received: June 19, 2000

Dear Dr. Myers:

We have reviewed your Section 510(k) 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 Quantel Packet Ultrasonic Pachymeter, as described in your premarket notification:

#### Transducer Model Number

P1 (20 MHz A-Scan)

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - George H. Myers, Sc.D.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" .

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at [phone].

Sincerely yours,

Daniel C. Sezom
Daniel G. Schultz, M.D.

Daniel G. Schultz, M.D. Captain, USPHS Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Quantel Medical

# Diagnostic Ultrasound Indications for Use Form

Page

510(k) Number (if known):

# Device Name: Quantel Medical S.A. ''Pocket'' Pachymeter

Intended Use: The Quantel Medical POCKET Ultrasonic Pachymeter is intended to be Intended Use: The Qualitel Mcdical I OCRET Offically of the some types of corneal surgery.

| CLINICAL<br>APPLICATION | A | B | M | PWD | CWD | COLOR<br>DOPPLER | POWER<br>(AMPLITUDE)<br>DOPPLER | COLOR<br>VELOCITY<br>IMAGING | COMBINED<br>(SPECIFY) | OTHER<br>(SPECIFY) |
|---------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------|
| Ophthalmic | N | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intra-operative<br>(specify) | | | | | | | | | | |
| Intra-operative<br>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:

## (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span></span> | (Per 21 CFR 810.109) |
|------------------|---------------|----------------------|
|------------------|---------------|----------------------|

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K993674 |
|---------------|---------|
|---------------|---------|

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