MODIFICATION OF: RHEO DOPPLEX II

K984307 · Huntleigh Healthcare, Inc. · IYN · Jan 12, 1999 · Radiology

Device Facts

• Record ID: K984307
• Device Name: MODIFICATION OF: RHEO DOPPLEX II
• Applicant: Huntleigh Healthcare, Inc.
• Product Code: IYN · Radiology
• Decision Date: Jan 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2

Intended Use

Venous photoplethysmography and bi-directional Doppler for venous and arterial assessment and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.

Device Story

Rheo Dopplex II is a diagnostic device for venous and arterial assessment; utilizes venous photoplethysmography and bi-directional Doppler technology. Device inputs include physiological signals from lower limb vasculature; processes these signals to provide clinicians with data regarding blood flow and venous status. Used in clinical settings by healthcare professionals to screen for absence of DVT. Output assists clinicians in confirming DVT absence, potentially reducing need for more invasive diagnostic procedures like venography. No changes to form, fit, function, or manufacture from original cleared device.

Clinical Evidence

Clinical studies compared Rheo Dopplex II against duplex imaging and venography for confirming absence of lower limb DVT. Results: Sensitivity 100%, Specificity 46%, Negative Predictive Value 100%, Positive Predictive Value 51%. Studies also confirmed repeatability and reproducibility.

Technological Characteristics

System utilizes venous photoplethysmography and bi-directional Doppler transducers (Models VP4, VP5, VP8, VP10). Operates as a peripheral vascular diagnostic tool. Complies with 21 CFR 892.1550 and 870.2780.

Indications for Use

Indicated for venous and arterial assessment and screening for the absence of deep venous thrombosis (DVT) in the lower limb in patients requiring vascular evaluation.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue 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)

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# JAN 1 2 1999

## 510(k) SUMMARY

| K Number: | K964699 K984307 |
|-----------------|--------------------------------------------------------|
| Product: | Rheo Dopplex® II |
| Company: | Huntleigh Healthcare Inc. |
| Address: | 227 Route 33 East<br>Manalapan, NJ 07726 |
| Contact Person: | Audrey Witko<br>Director of Corporate Affairs |
| | Phone: [phone], ext. 127<br>Fax: [phone] |

This is a supplemental 510(k) submission for expansion of the previously cleared Indications for Use (venous and arterial assessment) to include "screening for the absence of deep venous thrombosis (DVT) in the lower limb."

Clinical data to support this expanded Indications for Use include studies comparing the Rheo Dopplex® II with duplex imaging and venography for the confirmation of the absence of a DVT in the lower limb, with additional studies to confirm repeatability and reproducibility. The studies indicate that the Rheo Dopplex® II provides the following:

- . Sensitivity = 100%
- . Specificity = 46%
- . Negative Predictive Value = 100%
- . Positive Predictive Value = 51%

The Rheo Dopplex® II user manual has been amended to include the procedure and parameters for the screening of the absence of a Deep Venous Thrombosis (DVT) in the lower limb.

There is no change to the original form, fit, function, manufacture or clinical use of the Rheo Dopplex® II. All device safety data was included in the original premarket clearance.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the circle.

JAN 1 2 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Audrey Witko Director of Corporate Affairs Huntleigh Healthcare, Inc. 227 Route 33 East Manalapan, NJ 07726

Re: K984307 Rheo Dopplex II Regulatory Class: II/21 CFR 892.1550/21 CFR 870.2780 Product Code: 90 IYN/74 JOM Dated: December 1, 1998 Received: December 2, 1998

Dear Ms. Witko:

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 Rheo Dopplex II, as described in your premarket notification:

Transducer Model Number

VP4, VP5, VP8, VP10

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 Quality System Regulation (QS) 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.

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.

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Page 2 - Audrey Witko

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,

David C. Stegerson

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Center for Devices and Radiological Health

Page _ 1 of _1

510(k) Number (if known): #964699- K 984307

Device Name: Rheo Dopplex® II

Indications for Use:

Venous photoplethysmography and bi-directional Doppler for venous and arterial vonous protoproxity and for screening for the absence of deep venous thrombosis (DVT) in the lower limb.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Javid A. Seymore

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

(Optional Format 3-10-98)

(Posted July 1, 1998)

Back to the Indications for Use Page

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# Rheo Dopplex® System

K984307

## 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculoskeletal<br>Conventional | | | | | | | | | | |
| Musculo skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

Prescription Use (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (OD)

Yamil A. Seyson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological De

510(k) Number K984307

E-3

60

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.. --- No. 4305 r. 4/1

K984307

## 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculoskeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:

Prescription Use (Per 21 CFR 801.109)

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

Javid G. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

F-3

510(k) Number

65

{6}------------------------------------------------

No. 4305 P. 5/7

K984307

## Diagnostic Ultrasound Indications for Use Form

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

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

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

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

Additional Comments:

Prescription Use (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE Concurrence of CDRH, Office of Device Evaluation (ODE

Daniel C. Segers
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi

പ്പ്-3

510(k) Number

60

{7}------------------------------------------------

K984307

## 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal | | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | P | | | | | | | |
| 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:

Prescription Use (Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NE Concurrence of CDRH, Office of Device Evaluation (ODE

David C. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological I

510(k) Number

F-3

6d

{8}------------------------------------------------

r. 11/1 No. 43U5

K984307

# 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<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | P | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculoskeletal<br>Conventional | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | |

Other (specify) 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 PR Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

David G. Bergman
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dey

510(k) Number

E-3