ACCUPACH V

K042752 · Accutome Ultrasound, Inc. · IYO · Nov 10, 2004 · Radiology

Device Facts

• Record ID: K042752
• Device Name: ACCUPACH V
• Applicant: Accutome Ultrasound, Inc.
• Product Code: IYO · Radiology
• Decision Date: Nov 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.

Device Story

AccuPach V is an ultrasound pachymeter using pulsed echo technology to measure corneal thickness. The device utilizes an eye-contact probe to transmit and receive ultrasound pulses. It processes returning echoes to provide a numeric display of corneal thickness and calculates corrected intraocular pressure. Used in clinical settings by healthcare professionals. The output assists clinicians in evaluating ocular health and managing intraocular pressure, potentially benefiting patients by providing accurate corneal measurements for diagnostic purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasound pachymeter; 10.5 MHz A-mode probe; pulsed echo sensing principle; numeric display output; standalone device.

Indications for Use

Indicated for measuring corneal thickness and calculating corrected intraocular pressure in the human eye.

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

• Accutome Kremer Corneometer (K810660)

Submission Summary (Full Text)

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K042752

| NOV 1 0 2004 | 510(k) SUMMARY<br>AccuPach V | | | | | | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Applicant: | Accutome Inc. | | | | | | |
| Address: | 263 Great Valley Parkway<br>Malvern, PA 19355 | | | | | | |
| Contact Person: | Jeffrey L. Wright<br>Manager, Engineering, Manufacturing & QC | | | | | | |
| Telephone: | [phone]<br>[phone] fax | | | | | | |
| Preparation Date: | August 25, 2003 | | | | | | |
| Device Name: | AccuPach V | | | | | | |
| Common Name: | Ultrasound Pachymeter | | | | | | |
| Classification: | System, Imaging, Pulsed Echo, Ultrasonic<br>(see: 21 CFR 892.1560) Product Code: IYO Panel: 90 | | | | | | |
| Legally Marketed<br>Predicate Devices: | Accutome Kremer Corneometer (K810660) | | | | | | |
| Description of the Device: | The AccuPach V device is designed as an ultrasound<br>pachymeter which uses pulsed echo ultrasound to measure<br>the corneal thickness of the eye. It utilizes an eye-contact<br>probe to generate and receive the ultrasound pulses, and<br>provides a numeric display of returning pulse echoes to<br>indicate the thickness of the cornea. | | | | | | |
| Indications for Use: | The instrument is used for measuring the corneal thickness<br>of the eye. | | | | | | |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 0 2004

Mr. Jeffrey L. Wright Manager, Engineering, Manufacturing & QC Accutone, Inc. 263 Great Valley Parkway MALVERN PA 19355

Re: K042752

Trade Name: AccuPach V Pachymeter Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: October 4, 2004 Received: October 5, 2004

Dear Mr. Wright:

[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 AccuPach V Pachymeter, as described in your premarket notification:

#### Transducer Model Number

### 10.5 MHz A-Mode Probe

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.

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Page 2 - Mr. Wright - Carie

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 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".

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

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure(s)

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# AccuPach V 510(k) Notification

4.3 Indications for Use

510(k) Number (if known):____________

Device Name: AccuPach V

Indications for Use:

The instrument is used for measuring the corneal thickness of the eye, and calculating a corrected intraocular pressure based on those measurements.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

Nancy Brandon

(Division Sign-Off) Division of Reproductiv and Radiological Devices 510(k) Number

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# AccuPach V 510(k) Notification

### 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:

| Clinical Application | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | N | | | | | | | | | |
| 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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| 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)

Nancy J. Brogdon
(Division Sign-Off)

Division of Reproductive, Al and Radiological Devi 510(k) Number . K OH

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