DGH 55 HANDHELD PACHYMETER (PACHMATE)

K033385 · Dgh Technology, Inc. · IYO · Nov 7, 2003 · Radiology

Device Facts

• Record ID: K033385
• Device Name: DGH 55 HANDHELD PACHYMETER (PACHMATE)
• Applicant: Dgh Technology, Inc.
• Product Code: IYO · Radiology
• Decision Date: Nov 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Corneal thickness measurements are useful for screening potential laser refractive surgery patients, glaucoma screening, and monitoring corneal swelling. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic (A-mode).

Device Story

DGH 55 Handheld Pachymeter (Pachmate) is a handheld ultrasonic device used for measuring corneal thickness. It utilizes echo spike techniques to process ultrasonic signals. The device is operated by clinicians in an ophthalmic setting. It transforms ultrasonic echoes into thickness measurements, which are displayed to the provider. These measurements assist in clinical decision-making for refractive surgery screening, glaucoma management, and monitoring corneal edema. The device includes a detachable probe (DGH2006DET).

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including comparative corneal thickness measurements, water bath/phantom tests, electronic calibration verification, and compliance with safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37).

Technological Characteristics

Handheld ultrasonic pachymeter; uses echo spike technique for corneal thickness measurement. Includes DGH2006DET detachable probe. Features updated microprocessor and hardware compared to predicate. Operates in A-mode. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-37 standards.

Indications for Use

Indicated for ophthalmic use in patients requiring corneal thickness measurement, including those undergoing laser refractive surgery screening, glaucoma screening, or monitoring for corneal swelling.

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

• DGH 500 Ultrasonic Pachymeter (K920906A)

Submission Summary (Full Text)

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NOV - 7 2003

K033385
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## DGH Handheld Pachymeter 510(k) Summary

| Submitter: | DGH Technology, Inc.<br>110 Summit Drive, Suite B<br>Exton, PA 19341 |
|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | M. Luther Detweiler<br>Vice President, Regulatory Affairs |
| | Phone: [phone] / Fax: [phone]<br>E-mail: [e-mail] |
| Date summary prepared: | 10/7/2003 |
| Device trade name: | DGH 55 Handheld Pachymeter (Pachmate) |
| Device common name: | Ultrasound Pachymeter |
| Device classification name: | System, Imaging, Pulsed Echo, Ultrasonic |
| Legally marketed devices<br>to which the device is<br>substantially equivalent: | DGH 500 Ultrasonic Pachymeter (K920906A) |
| Description of device: | The DGH 55 is a handheld ultrasonic pachymeter<br>that uses echo spike techniques to measure the<br>thickness of the cornea. |
| Intended use of the device: | Corneal thickness measurements are useful for<br>screening potential laser refractive surgery patients,<br>glaucoma screening, and monitoring corneal<br>swelling. |
| Technological characteristics: | The technological characteristics are unchanged<br>from the predicate device. The new microprocessor<br>and associated hardware, and the new software<br>implement the same algorithmic approach as the<br>predicate device. The changes represent technology<br>updates without changing functionality. |

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Performance tests:

The following tests were performed to demonstrate substantial equivalence:

- □□ Comparative corneal thickness measurement tests
- □□ Comparative water bath/phantom tests
- 口 Comparative electronic calibration verification tests
- □□ EN 60601-1: Medical electrical equipment -Part 1: General requirements for safety -IEC 601-1.
- DO EN 60601-1-2: Medical electrical equipment -Part 1: General requirements for safety. Collateral standard: Electromagnetic compatibility requirements and tests. IEC 60101-2, and
- □□ IEC 60601-2-37: Medical electrical equipment Part 2 - 37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (Clause 42.3 tested under condition 2 only.)
- □□ Acoustic Output Reporting per section 4.6 of FDA Document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" issued on September 30, 1997.

Conclusions: The results of the performance tests demonstrate that the device is substantially equivalent to the legally marketed predicate device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human figures connected at the shoulders, forming a sort of abstract bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 7 2003

DGH Technology, Inc. % Mr. N. E. Devine, Jr. Responsible Third Party Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K033385

Trade Name: DGH 55 Handheld Pachymeter (Pachmate) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasound pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: October 7, 2003 Received: October 23, 2003

Dear Mr. Devine:

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 DGH 55 Handheld Pachymeter (Pachmate), as described in your premarket notification:

### Transducer Model Number

#### DGH2006DET

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);

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labeling (21 CFR Part 801); 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.

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. Brogdon 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

# Fill out one form for each ultrasound system and each transducer.

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| | | | | | | Mode of Operation | | | | |
|-------------------------------|---|---|---|-----|-----|-------------------|-------------------|------------------------|--------------------|-----------------|
| Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) |
| Ophthalmic | P | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments: Above indication for use is for the DGH55 Handheld Pachymeter with the DGH2006DET Detachable Probe.

(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) Division Sign-Off)

Division of Reproductive, Abdominal Radiological Devices

510(k) Number K033385

Kk) Number ___________________________________________________________________________________________________________________________________________________________________