LIFEDOP MODEL, L350R

K090499 · Summit Doppler Systems, Inc. · MAA · Mar 31, 2009 · Obstetrics/Gynecology

Device Facts

• Record ID: K090499
• Device Name: LIFEDOP MODEL, L350R
• Applicant: Summit Doppler Systems, Inc.
• Product Code: MAA · Obstetrics/Gynecology
• Decision Date: Mar 31, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Obstetrical: This product will be used to detect fetal heart beats as an aid for determining fetal viability. Vascular: This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Device Story

Portable, battery-powered Doppler ultrasound device; table-top, stand, or wall-mounted. Uses continuous wave (CW) ultrasound transducers (2.1, 3.2, 4.0, 8.0 MHz) to detect fetal heart beats or vascular blood flow. Operates by emitting ultrasound waves into tissue; reflected signals processed to produce audible output. Used by clinicians in clinical settings. Output provides real-time auditory feedback of fetal heart rate or vascular flow, aiding clinical assessment of fetal viability and peripheral vascular disease detection.

Clinical Evidence

No clinical data provided. Substantial equivalence established through comparison of device features, materials, intended use, and performance characteristics to the predicate device.

Technological Characteristics

Portable, battery-powered Doppler ultrasound system. Utilizes continuous wave (CW) ultrasound transducers at 2.1 MHz, 3.2 MHz, 4.0 MHz, and 8.0 MHz. Form factor designed for table-top, stand, or wall mounting. No complex software algorithms or connectivity specified.

Indications for Use

Indicated for detection of fetal heart beats to determine fetal viability and detection of blood flow in veins and arteries to assist in diagnosis of peripheral vascular disease. Intended for use with 2.1/3.2 MHz CW fetal probes and 4.0/8.0 MHz CW vascular probes.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• LifeDop Doppler Ultrasound System (K024197)

Submission Summary (Full Text)

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K090499

MAR 3 1 2009

#### SAFETY AND EFFECTIVENESS SUMMARY Summit Doppler Systems, Inc. LifeDop 350 Doppler

Name and Address:

Summit Doppler Systems, Inc. 4680 Table Mountain Dr. #150 Golden, CO 80403

Phone: [phone] Fax: [phone]

Ken Jarrell - President

January 16, 2009

LifeDop 350 Doppler

Portable Doppler, Fetal and Vascular

FR Number Class II per: . 884.2660 Monitor, Ultrasonic, Fetal 884.2660 Monitor, Bloodflow, Ultrasonic

Product Code KNG HEP

Obstetric (2.1 and 3.2 MHz Probes) This product will be used to detect fetal heart beats as an aid for determining fetal viability.

Vascular (4.0 and 8.0 MHz Probes) This product will be used to detect blood flow in veins and arterics for assisting in the detection of peripheral vascular disease.

The LifeDop 350 Doppler is a portable, battery-powered ultrasound device used for detecting fetal heart beats and also for blood flow detection in veins and arteries. Primarily intended to be table-top, stand or wall mounted.

Summit Doppler Systems Golden, CO LifeDop Doppler Ultrasound System K024197, Cleared 1/3/03

Doppler ultrasound technology is the same as substantially equivalent device shown above.

None provided

Based on comparisons of device features, materials, intended use and performance, the LifeDop 350 Doppler is shown to be substantially equivalent to the commercially available and legally marketed device indicated above.

Contact:

Preparation Date:

Device Name:

Common Name:

Classification:

Indications for Use:

Description:

Substantial Equivalence:

Technologies Summary:

Clinical Testing:

Conclusion:

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Summit Doppler Systems, Inc. % Ms. Dawn Tibodeau Program Manager, Responsible Third Party Official TÜV SÜD America, Inc. 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891

MAR 3 1 2009

Re: K090499

Trade/Device Name: LifeDop 350 Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: MAA Dated: March 16, 2009 Received: March 18, 2009

Dear Ms. Tibodeau:

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 LifeDop 350 Doppler, as described in your premarket notification:

Transducer Model Number

SD2 -- 2.1 MHz CW Fetal Probe SD3 - 3.2 MHz CW Fetal Probe SD4 - 4.0 MHz CW Peripheral Vascular Probe SD8 - 8.0 MHz CW Peripheral Vascular Probe

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Page 2 - Ms. Tibodeau

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); 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 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/cdrb/industry/support/index.html

If you have any questions regarding the content of this letter, please contact Paul Hardy at [phone].

Sincerely yours.

ne M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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# Indications for Use

510(k) Number:

Device Name:

Indications for Use:

K090499

LifeDop 350 Doppler

#### Obstetrical:

This product will be used to detect fetal heart beats as an aid for determining fetal viability.

Vascular:

This product will also be used to detect blood flow in veins and arteries for assisting in the detection of peripheral vascular disease.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter-Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hula Reum

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

Page 1 of 1

Addendum sheet 2 of 6

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## Attachment C - Indication for Use

### Diagnostic Ultrasound Indications for Use Form

### Main unit fetal system with either 2.1 MHz CW or 3.2 MHz CW Main unit peripheral vascular system with either 4.0 MHz CW 8.0 MHz CW

Man unit perfoneral vasound 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 | | | | | | | | | | | |
| Fetal | | | | | P | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethal | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Peripheral Vascular | | | | | P | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other (specify) | | | | | | | | | | | |

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

Additional Comments: 2.1 MHz CW Fetal Probe - Previously cleared K024197

3.2 MHz CW Fetal Probe - Previously cleared K024197

3.2 MHz CW Fetal Probe - Previously cleared K024197

4.0 MHz CW PV Probe - Previously cleared K024197

8.0 MHz CW PV Probe - Previously cleared K024197

Neil A. Clemm

THE EVSE DO NOT MATE BETOM THIS TIME - CONTIMIE ON WAOTHER EVEE TE REEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Reproductive, Abdominal a Radiological Devices 510(k) Number

Prescription Use (Per 21 CRF 801.109)

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#### SD2 - 2.1 MHz CW Fetal Probe

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 | | | | | P | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| 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: __ Previously cleared on K024197, cleared 1/3/03

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

Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form

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

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

### SD3 — 3.2 MHz CW Fetal Probe

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 | | | | P | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethal | | | | | | | | | | |
| 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: ____Previously cleared on K024197, cleared 1/3/03_

510(k) Number

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

Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form

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

28

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

## SD4 – 4.0 MHz CW Peripheral Vascular Probe

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 | | | | | | | | | | |
| 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 Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Previously cleared on K024197, cleared 1/3/03 Additional Comments: _

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

Prescription Use (Per 21 CRF 801.109) Diagnostic Ukrasound Indications for Use Form

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K090499

29.

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

### SD8 – 8.0 MHz CW Peripheral Vascular Probe

SD8 – 8.0 MHz CW Penpheral Vascular Probe
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 | | | | | | | | | | | |
| Smali Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethal | | | | | | | | | | | |
| 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: __ Previously cleared on K024197, cleared 1/3/03THE EASE DO NOT WRITE BELOW THIS LINE - CONTIMUE ON ANDILIERS PAGE IS NEEDED. DONCLURITE DECOM Office of Device Evaluation (ODE)

Prescription Use (Per 21 CRF 801.109) Diagnostic Ultrasound Indications for Use Form

(Division Sign-Off)
Division of Reproductive, Abdominal and

- Radiological Devices 510(k) Number

ﺍﻟﻘﺪ ﺗﺼﻔﻴﺎﺕ

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