NICOLET VERSALAB

K010521 · Nicolet Biomedical · JAF · Mar 9, 2001 · Radiology

Device Facts

• Record ID: K010521
• Device Name: NICOLET VERSALAB
• Applicant: Nicolet Biomedical
• Product Code: JAF · Radiology
• Decision Date: Mar 9, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1540
• Device Class: Class 2

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body.

Device Story

Nicolet VersaLab is a diagnostic ultrasound system utilizing 4 MHz and 8 MHz continuous wave (CW) Doppler transducers. Device emits ultrasound signals for blood-flow analysis; operates at fixed, non-adjustable power levels below 720 mW/cm2 to ensure ALARA compliance. System is DC rechargeable battery or DC powered. Operated by or on order of a physician in clinical settings. Provides blood-flow information to assist clinicians in making diagnostic judgments. Hardware and redundant software controls manage power output. Benefits include non-invasive assessment of vascular flow.

Clinical Evidence

Bench testing only. Device complies with FDA recommended maximum exposure limits for ultrasound (720 mW/cm2). No clinical data provided.

Technological Characteristics

Diagnostic ultrasound system; 4 MHz and 8 MHz CW directional transducers; fixed CW Doppler power levels; DC rechargeable battery/DC powered; hardware and redundant software power controls.

Indications for Use

Indicated for peripheral vascular diagnostic ultrasound imaging or fluid flow analysis in patients requiring vascular assessment.

Regulatory Classification

Identification

A nonfetal ultrasonic monitor is a device that projects a continuous high-frequency sound wave into body tissue other than a fetus to determine frequency changes (doppler shift) in the reflected wave and is intended for use in the investigation of nonfetal blood flow and other nonfetal body tissues in motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Submission Summary (Full Text)

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

## SUMMARY OF SAFETY and EFFECTIVENESS

Instrument Safety:

- Ultrasound signals are emitted at power levels below FDA recommended maximum exposure limits of 720 mW / cm2-
- The Nicolet VersaLab is labeled for use by or on order of a physician.
- The Nicolet VersaLab is a DC rechargeable battery / DC powered device.

Good Clinical Practice dictates that ultrasound equipment, including the Nicolet VersaLab, should be operated at power levels As Low As Reasonably Achievable [ALARA]. This means that the operator uses Doppler power levels no higher that necessary to obtain blood-flow information that is adequate to make clinical judgements. The Nicolet VersaLab employs fixed [not adjustable] CW Doppler power levels that are pre-set at a limit below the maximum allowable of 720mw/cm²; therefore, the ALARA condition is always met. There are hardware levels controlling the power as well as redundant software controls.

Ultrasound Safety:

The American Institute of Ultrasound in Medicine has issued the following statement concerning the safety of ultrasound:

" No confirmed biological effects on patients or instrument operators caused by exposure at intensities typical of present diagnostic ultrasound instruments have been reported. Although the possibility exists that such biological effects may be identified in the future, current data indicate that the benefits to patients of the prudent use of diagnostic ultrasound outweighs the risks, if any, that may be present".

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

MAR - 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Wagner Director, Quality Assurance and Regulatory Affairs Nicolet Vascular, Inc. 6355 Joyce Drive GOLDEN CO 80403

Re: K010521

Trade Name: Nicolet VersaLab Regulatory Class: II/21 CFR 892.1540/21 CFR 870.2880 Product Code: 90 JAF/90 JOP Dated: February 15, 2001 Received: February 22, 2001

Dear Mr. Wagner:

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 Nicolet VersaLab, as described in your premarket notification:

Transducer Model Numbers:

### 4 MHz (CWD) 8 MHz (CWD)

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 Ouality System Regulation (OS) 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 regulatory 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.

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

This determination of substantial equivalence is granted on the condition that prior to shipping the first I mo determination it 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 misbrained they not appris to and phould 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 sybstantial 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Daniel C. Lyzman

David A. Segerson Acting Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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

## 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 all follows:

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

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

Additional Comments: (N) SYSTEM UTILIZES IEA 4 MHZ AND 8MHZ CW DIRECTIONAL PROBES

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|--------------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K010521 |

Prescription Use (Per 21 CFR 801.109)

F-3

Prescription Use

{4}------------------------------------------------

### ABARAR 1100% 1-50 INVEDUCEK BMHZ

#

Fill Out one form (2) and 100 analysis of the human body age follows:

Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of

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

| Prescription Use (Per 21 CFR 801.109) | <p>✓</p> |
|---------------------------------------|----------|
|---------------------------------------|----------|

F-3

(Division Sign-Off

Division of Reproductive

and Radiological D

510(k) Number K010561

{5}------------------------------------------------

Prescription Use

## Diagnostic Ultrasound Indications for Use Form

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

liter and the our in our of the enalysis of the human body as the human body as tollows:

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

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

Prescription Use (Per 21 CFR 801.109)

510(k) Number K01031