IOP8 INTRA OPERATIVE PROBE

K032315 · Huntleigh Healthcare, Inc. · ITX · Nov 18, 2004 · Radiology

Device Facts

• Record ID: K032315
• Device Name: IOP8 INTRA OPERATIVE PROBE
• Applicant: Huntleigh Healthcare, Inc.
• Product Code: ITX · Radiology
• Decision Date: Nov 18, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1570
• Device Class: Class 2

Intended Use

The IOP8 is a passive, self contained, sterilizable, reusable, Pulsed Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting. The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.

Device Story

IOP8 is an 8MHz passive, sterilizable, pulsed-wave (PW) Doppler pencil probe; consists of stainless steel tube housing PZT crystal protected by faceplate. Connects via cable to PA8 interconnection adapter containing bi-directional electronics; adapter interfaces with compatible Huntleigh Doppler control units (MD200, SD2, RD2, D900, MD2). Used intraoperatively by surgeons to assess blood flow on vessel surfaces; probe does not enter vessels or contact blood. Provides audible/visual blood flow feedback to assist in confirming success of vascular reconstructive procedures. System requires external sterilization of probe; adapter and control units remain outside sterile field. Benefits include real-time intraoperative assessment of vascular patency and graft success.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on technological characteristics and performance testing of the 8MHz transducer and associated electronics compared to the predicate device.

Technological Characteristics

8MHz pulsed-wave Doppler transducer; stainless steel probe housing; PZT crystal; interconnection cable with connector system for sterilization; PA8 adapter for bi-directional signal processing; compatible with existing Huntleigh Doppler control units. Sterilization: probe is sterilizable; adapter/control units are non-sterilizable. Connectivity: wired interface to proprietary control units.

Indications for Use

Indicated for intraoperative blood flow monitoring in patients undergoing vascular reconstructive procedures, including carotid endarterectomy, femoro-popliteal bypass, in-situ femoro-distal bypass, arterio-venous fistulae detection, renal blood flow confirmation post-aortic aneurysm repair, coronary artery bypass grafts, and renal/hepatic transplantation.

Regulatory Classification

Identification

A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.

Predicate Devices

• Dopplex Surgical Probes (DSP) (K946300)

Reference Devices

• MD200 (K930200)
• SD2 (K930200)
• RD2 (K984307)
• D900 (K900882)
• MD2 (K930200)

Submission Summary (Full Text)

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

K032315

Diagnostic Products Division

Image /page/0/Picture/2 description: The image shows the logo for Huntleigh Healthcare. The logo consists of a stylized graphic to the left of the text. The graphic is made up of several horizontal lines that are stacked on top of each other, with a vertical line running through the center. To the right of the graphic is the word "Huntleigh" in a serif font, with the word "HEALTHCARE" in a smaller, sans-serif font below it.

NOV 1 8 2004

Appendix C – 510(k) Summary

# Intra Operative Probe – IOP8

| Submitter's Name: | Ms Audrey A. Witko,<br>Vice President - Corporate & Clinical Affairs<br>Huntleigh Healthcare Inc,<br>40 Christopher Way<br>Eatontown, NJ 07724-3327<br>USA |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone N°: | [phone] ext. 127 |
| Fax N°: | [phone] |
| e-mail: | [e-mail] |
| Name of Device: | Intra Operative Probe (IOP8) |
| Manufactured by: | Huntleigh Healthcare Ltd (Diagnostic Products Division<br>35, Portmanmoor Road,<br>Cardiff<br>South Glamorgan CF24 5HN<br>Wales, U.K. |
| Contact Person at Manufacturing Facility: | B.J.Colleypriest |
| Telephone N°: | [phone] |
| Fax N°: | [phone] |
| e-mail: | [e-mail] |
| Date summary prepared: | 19 November 2003 |
| Classification Name | Transducer, Ultrasonic, Diagnostic |

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

Image /page/1/Picture/1 description: The image shows the logo for Huntleigh Healthcare. The logo consists of a stylized symbol on the left and the text "Huntleigh" above the text "HEALTHCARE" on the right. The symbol is made up of several horizontal lines that are stacked on top of each other, with small gaps in between.

## Predicate Devices

The IOP8 is substantially equivalent to the Dopplex Surgical Probes (DSP) manufactured by Huntleigh Healthcare, which are no longer in production. The DSP has previously been reviewed by the FDA, and cleared by certificate number K946300. The previous application covered 3 different models viz: IOP10, IOP10A & LOP10. Substantial equivalence for the new IOP8 is claimed against the predicate IOP10A model only.

The applicant IOP8 and its associated PA8 Adapter are only for use with Dopplex devices manufactured by Huntleigh Healthcare Ltd.

## Device Description

The IOP8 consists of a small diameter stainless steel tube and an interconnection cable. The tube houses a PZT crystal that is protected by a faceplate. A cable links the IOP8 probe tube to an interconnection adapter (designated PA8) that houses the bi-directional electronics. This adapter in turn connects to a main Doppler unit, which is required to drive the IOP8 / PA8 system.

A connector system at the end of the cable allows the IOP8 to be removed and externally sterilized before use. The interconnection adapter and main Doppler unit(s) are not sterilizable, and remain outside the sterile field.

## Product Summary

The IOP8 is a passive, self contained, sterilisable, PW Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting.

The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.

A connector system at the end of the cable allows the IOP8 to be removed and externally sterilized. An interconnection adapter, housing the bi-directional electronics, is employed. which connects to the main Doppler unit. When connected in this way, the Hand Held Doppler units operate as if a normal VP8 probe is connected.

The following list outlines the Huntleigh Doppler units that can be used with the IOP8:

- ப D900
- ු SD2
- MD2 with waveform recording to Dopplex Printa or Dopplex Reporter running on a computer.
- RD2 with waveform recording to Dopplex Printa or Dopplex Reporter running 0 on a computer.
- MD200 with waveform recording to Dopplex Printa or Dopplex Reporter ப running on a computer

### Accessories

An Interconnection Adapter (PA8) is required to interface between the 10P8 and the Dopplex main unit. This adapter and the Dopplex main unit are not designed to be sterilized and must remain outside the sterile field.

An IV Pole Clamp (Ref № ACC47) is available, that allows the Doppler unit to be conveniently outside the sterile field in a position that permits easy access to the controls and, if used, the LCD display.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Mr. Phillip Morris Technical Manager Huntleigh Healthcare, Inc. Diagnostics Products Division 35 Portmanmoor Road Cardiff., CF24 5HN UNITED KINGDOM

Re: K032315

Trade Name: IOP8 Intra Operative Probe Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasound transducer Regulatory Class: II Product Code: 90 ITX Dated: October 21, 2004 Received: October 25, 2004

Dear Mr. Morris:

· 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 control units intended for use with the IOP8 Intra Operative Probe and the PA8 Adaptor, as described in your premarket notification:

## Control Unit Model Number

| MD200 |
|-------|
| SD2 |
| RD2 |
| D900 |
| MD2 |

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

## Page 2 - Mr. Morris

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 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".

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

Page 3 – Mr. Morris

ﺩ

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

Sincerely yours,

David A. Ayres

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

.

100 million in the state

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ﺎﺕ Enclosure(s)

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

Image /page/5/Picture/1 description: The image shows the logo for Huntleigh Healthcare. The logo consists of a stylized symbol on the left and the company name on the right. The symbol is made up of several horizontal lines that are stacked on top of each other, with a gap in the middle. The text "Huntleigh" is in a larger font size than the text "HEALTHCARE", which is located below it.

## Appendix F - Indications For Use Summary

510(k) Number (if known):

K032315

Device Name:

Intra Operative Probe (IOP8)

## Indications for Use

The 10P8 is a passive, self contained, sterilizable, reusable, Pulsed Doppler pencil probe. It enables easy detection of blood flow in vessels of varying diameters, providing evidence of success in vascular reconstructive procedures, including skin grafting.

The IOP will be located on the surface of vessels to assist in the assessment of blood flow. The probe will not be inserted into vessels and does not contact circulating blood.

## (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 ____

(Per 21 CFR 801.109)

David A. Lyman

(Division Sign-Off) (Division Sign-On)
Dunsion of Reproductive, Abdomi an Devices Devices 51:1(k) Number --

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

#### 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) | | | | N | | | | | | |
| 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:_The IOP8 is an 8MHz ultrasound probe used in conjunction with a PA8 adaptor and a control unit.

The IOP8/PA8 combination together with a MD200 control unit (K930200) would be used to monitor blood flow intra-operatively.

Typical clinical applications include: Carotid endarterectorny, Femoro-popliteal bypass, In-situ femoro-distal bypass,

Detection of arterio-venus fistulae, Confirmation of renal blood flow following aortic aneurysm repair,

Coronary artery bypass grafts, Renal and hepatic transplantation, intraoperative blood flow monitoring

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

David b. hogson

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) 4
Division of Reproductive, Abdominal,
and Radiological Devices
F-3 510(k) Number K032315

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

## 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 | 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) | | | | N | | | | | | |
| 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: _ The IOP8 is an 8MHz ultrasound probe used in conjunction with a PA8 adaptor and a control unit.

The IOP8/PA8 combination together with a SD2 control unit (K930200) would be used to monitor blood flow intra-operatively.

Typical clinical applications include: Carolid endarterectorny, Femoro-popliteal bypass, In-situ femoro-distal bypass,

Detection of arterio-venus fistulae, Confirmation of renal blood flow following aortic aneurysm repair,

Coronary artery bypass grafts, Renal and hepatic transplantation, intraoperative blood flow monitoring

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

David h. Lyman

Prescription Use (Per 21 CFR 801.109)

Division Sia 510(k) E-3

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

#### 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) | | | | N | | | | | | |
| 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) | | | | | | | | | | |

added under Appendix b indication, I previously created by FLUA, E=

Additional Comments: The IOP8 is an 8MHz ultrasound probe used in conjunction with a PA8 adaptor and a control unit.

The IOP8/PA8 combination together with a RD2 control unit (K984307) would be used to monitor blood flow intra-operatively.

Typical clinical applications include: Carotid endarterectorny, Femoro-popliteal bypass, In-situ femoro-distal bypass,

Detection of arterio-venus fistulae, Confirmation of renal blood flow following aortic aneurysm repair,

Coronary artery bypass grafts, Renal and hepatic transplanlation, intraoperative blood flow monitoring

(PLEASE DO HOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyssorn

Prescription Use (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, and Radiological Devices F \$10(k) Number

{9}------------------------------------------------

#### 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 | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative (specify) | | | | N | | | | | | |
| 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) | | | | | | | | | | |

Additional Comments: _ The IOP8 is an 8MHz ultrasound probe used in conjunction with a PA8 adaptor and a control unit.

The IOP8/PA8 combination together with a D900 control unit (K900882) would be used to monitor blood flow intra-operatively.

Typical clinical applications include: Carolid endarterectorny, Femoro-popliteal bypass, In-situ femoro-distal bypass,

Detection of arterio-venus fistulae, Confirmation of renal blood flow following aortic aneurysm repair,

Coronary artery bypass grafts, Renal and hepatic transplantation, intraoperative blood flow monitoring

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

Daniel br. Lawson

Prescription Use (Per 21 CFR 801.109)

F-3
(Division Sign-Off)
Division of Reproductive, Abdominal,
anni Radiological Devices
510(k) Number K032315

{10}------------------------------------------------

#### 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) | | | | N | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculoskeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |

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

Additional Comments:_The IOP8 is an 8MHz ultrasound probe used in conjunction with a PA8 adaptor and a control unit.

The IOP8/PA8 combination together with a MD2 control unit (K930200) would be used to monitor blood flow intra-operatively,

Typical clinical applications include: Carotid endarterectorny, Femoro-popliteal bypass, In-situ femoro-distal bypass,

Detection of arterio-venus fistulae, Confirmation of renal blood flow following aortic aneurysm repair,

Coronary artery bypass grafts, Renal and hepatic transplantation, intraoperative blood flow monitoring

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

David h. Lymann

Prescription Use (Per 21 CFR 801.109)

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