PACHPEN PACHYMETER, MODEL 24-5100

K050552 · Accutome, Inc. · IYO · Mar 28, 2005 · Radiology

Device Facts

• Record ID: K050552
• Device Name: PACHPEN PACHYMETER, MODEL 24-5100
• Applicant: Accutome, Inc.
• Product Code: IYO · Radiology
• Decision Date: Mar 28, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The instrument is used for measuring the corneal thickness of the eye.

Device Story

PachPen Pachymeter is an ultrasound device for measuring corneal thickness. It utilizes an eye-contact probe to emit pulsed echo ultrasound pulses into the eye; the probe receives returning echoes. The device processes these echoes to calculate and display a numeric value representing corneal thickness. Used in clinical settings by healthcare professionals. The output provides objective measurements of corneal thickness, assisting clinicians in diagnostic assessments of the eye. The device benefits patients by providing accurate, non-invasive corneal thickness data.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Ultrasound pachymeter; A-mode operation; 10.5 MHz transducer; pulsed echo sensing principle; numeric display output.

Indications for Use

Indicated for measuring corneal thickness of the eye using A-mode ultrasound.

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

• AccuPach V Pachymeter (K042752)

Submission Summary (Full Text)

{0}------------------------------------------------

K05055 2

## MAR 2 8 2005

.

# 510(k) SUMMARY

| Applicant: | Accutome Inc. |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 263 Great Valley Parkway<br>Malvem, PA 19355 |
| Contact Person: | Jeffrey L. Wright<br>Manager, Engineering, Manufacturing & QC |
| Telephone: | [phone]<br>[phone] fax |
| Preparation Date: | February 28, 2005 |
| Device Name: | PachPen Pachymeter |
| 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: | AccuPach V Pachymeter (K042752) |
| Description of the Device: | The PachPen 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. |

{1}------------------------------------------------

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings or feathers.

MAR 2 8 2005

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K050552

Trade Name: PachPen Pachymeter Regulation Number: 21 CFR 892.1650 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: February 28, 2005 Received: March 7, 2005

Dear Mr. Wright:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Booken or resped the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the Merror, 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 Cosmone Act (110). "The general controls provisions of the Act include requirements for annual provision, 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 PachPen Pachymeter, as described in your premarket notification:

#### Transducer Model Number

#### A-mode 10.5 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);

{2}------------------------------------------------

Page 2 - Mr. Wright

labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality labeling (21 OF R Part 807), good mart 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 nnonmation, meraling working works September 30, 1997 "Information for Manufacturers Seeking Appendix O; (enerobed) oversic 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

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

Sincerely yours,

Nancyc Brogdon

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

Enclosure(s)

{3}------------------------------------------------

# PachPen 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:

| | 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<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:_

Transducer used is the one used in AccuPach V K042752.

(PLE ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Nancy C Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number _