POD PAC-20M

K030610 · Portable Ophthalmic Devices, Inc. · IYO · Mar 21, 2003 · Radiology

Device Facts

• Record ID: K030610
• Device Name: POD PAC-20M
• Applicant: Portable Ophthalmic Devices, Inc.
• Product Code: IYO · Radiology
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

To measure thickness of the cornea in the human eye using ultrasound energy.

Device Story

POD Pac-20m is an ultrasonic corneal pachymeter; uses ultrasound energy to measure corneal thickness. Device utilizes Blatek 20 MHz transducer; operates in A-mode. Used in clinical ophthalmic settings; operated by eye care professionals. Provides quantitative corneal thickness measurements; assists clinicians in evaluating corneal health and surgical planning. Benefits include non-invasive, precise measurement of corneal tissue.

Clinical Evidence

Bench testing only. Acoustic output measurements were performed to ensure compliance with FDA guidance for diagnostic ultrasound systems.

Technological Characteristics

Ultrasonic pulsed echo imaging system; 20 MHz transducer (Blatek AT15399/AT15387); A-mode operation. Patient-contact materials are identical to predicate. Device is a standalone ophthalmic pachymeter.

Indications for Use

Indicated for measuring corneal thickness in human eyes using ultrasound energy. No specific age or gender restrictions provided.

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

• Quantel 'Pocket' Ultrasonic Pachymeter (K993674)

Submission Summary (Full Text)

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K030610

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

I. Submitter: Tim Ehrecke, Portable Ophthalmic Devices, Inc. 4413 Winston Place, Bettendorf, Iowa 52722. FAX [phone] Ph: 563-529-3536

MAR 2 1 2003

| II. Classification Names and Numbers: | Ultrasonic Pulsed Echo Imaging System,<br>90-IYO, 21CFR892.1560 |
|---------------------------------------|-----------------------------------------------------------------|
| III. Common/Usual Name: | Ultrasonic Corneal Pachymeter |
| IV. Proprietary Names: | POD Pac-20m™ |
| V. Establishment Registration Number: | in progress |
| VI. Classification: | Class II, Tier II. Described in 21CFR892.1560 |

VII. Substantial Equivalence: We believe the POD Pac-20m™ is substantially equivalent to the classified device described in 21CFR892.1560, "Ultrasonic Pulsed Echo Imaging System," and to other ultrasound systems that have been cleared by the 510(k) process, such as the Quantel "Pocket" Ultrasonic Pachymeter (K993674).

The 510(k) Substantial Equivalence Decision-making Process (detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

1. These products have the same intended use, to measure the thickness of the cornea.

2. The technological characteristics of this device are the same as those for the predicate device except for the models of some of the components, and the user interface.

3. The materials from which the patient-contact portions of the device are made are the same as in the predicate device.

4. The acoustic output of this device is similar to that of predicate devices and below the preamendment levels described in the guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers."

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Image /page/1/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, resembling a family or group.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2003

Mr. Tim Ehrecke President and CEO Portable Ophthalmic Devices, Inc. 4413 Winston Place BETTENDORF IA 52772

Re: K030610

Trade Name: POD Pac-20m Corneal Pachymeter System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: February 25, 2003 Received: February 26, 2003

Dear Mr. Ehrecke:

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 POD Pac-20m Corneal Pachymeter System, as described in your premarket notification:

Transducer Model Number

## Blatek AT15399/AT15387 (20 MHz)

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 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); 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.

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This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free 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,

Nancy C. Brogdon

Nancy C. B ogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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## Diagnostic Ultrasound Indications for Use Form

510(k) Number: K030 610

Device Name: POD Pac-20m Corneal Pachymeter System

| Intended Use: | To measure thickness of the cornea in the human eye using ultrasound energy. |
|---------------|------------------------------------------------------------------------------|
|---------------|------------------------------------------------------------------------------|

| Clinic al App lication | | Mode of Operation | | | | | | | | |
|-------------------------------------|---|-------------------|---|------|-----|-------------------|-----------------------|------------------------------|------------------------|--------------------|
| | A | B | M | PW D | CWD | Color<br>Dop pler | Amplitude<br>Dop pler | Color<br>Velocity<br>Imaging | Com bined<br>(specify) | Other<br>(specify) |
| O ph thalm ic | N | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Ab dom inal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative N eurologic al | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal C ephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Trans rectal | | | | | | | | | | |
| Trans vaginal | | | | | | | | | | |
| Trans urethr al | | | | | | | | | | |
| Intravasc ular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparos cop ic | | | | | | | | | | |
| Mu sculo-s keletal<br>Con ventional | | | | | | | | | | |
| Mu sculo-s keletal<br>Su perficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

N= new indication; P= previously cleared by FDA; E= added under Appendix E

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 (Per 21 CFR 801.109)

Nancy Cbrogdon
(Division Sign-Om)
Division of Reprodative, Abdominal,

510k

.