JOSTRA FLOWPROBE FP-32E

K013939 · Jostra AG · DPT · Dec 14, 2001 · Cardiovascular

Device Facts

• Record ID: K013939
• Device Name: JOSTRA FLOWPROBE FP-32E
• Applicant: Jostra AG
• Product Code: DPT · Cardiovascular
• Decision Date: Dec 14, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Jostra Flowprobe FP-32E is intended to be used as a flow measuring device in procedures requiring extracorporeal circulation for 6 hours or less.

Device Story

Jostra Flowprobe FP-32E is a single-use, sterile, 3/8" polycarbonate electromagnetic blood flow transducer. Used in extracorporeal circulation procedures for monitoring blood flow for up to 6 hours. Operates as a flow measuring device within extracorporeal circuits. Intended for clinical use by healthcare professionals. Provides flow measurement data to assist in monitoring patient status during procedures.

Clinical Evidence

Bench testing only. Performance testing included flow measurement accuracy, pressure testing, and electrical safety. In-vitro testing was conducted to evaluate effects on cellular components. No clinical data provided.

Technological Characteristics

Materials: Polycarbonate. Dimensions: 3/8" size. Sensing principle: Electromagnetic blood flow transducer. Single-use, sterile device. No software or electronic processing described beyond basic transducer function.

Indications for Use

Indicated for use as a flow measuring device in extracorporeal circuits for up to 6 hours.

Regulatory Classification

Identification

An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

Predicate Devices

• Medtronic-BioMedicus DP-38 Bio-Probe

Submission Summary (Full Text)

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| 510 (K) Summary | DEC 1 4 2001 | | K013939 |
|-----------------------|------------------------------------------------------------------|--|---------|
| Submitter: | Jostra AG<br>Hechinger Straße 38<br>72145 Hirrlingen<br>Germany | | |
| Contact Person: | Kathleen Johnson<br>Phone: [phone]<br>Fax: [phone] | | |
| Date Prepared: | October 15, 2001 | | |
| Device Trade Name: | Jostra Flowprobe FP-32E | | |
| Common/Usual Name: | Flowprobe | | |
| Classification Names: | Extracorporeal Blood Flow Probe | | |
| Predicate Device: | Medtronic-BioMedicus DP-38 Bio-Probe | | |

Device Description:

The Jostra Flowprobe FP-32E is a single, sterile device for single use only and not to The Jostra Flowprobe TF OLE IS a cingle, comment of the sure blood flow during De restentized by the user. The flowprobe is made from polycarbonate and is available in a 3/8" size.

Indications for use:

The Jostra Flowprobe FP-32E is intended to be used as a flow measuring device in procedures requiring extracorporeal circulation for 6 hours or less.

Statement of Technical Characteristics Comparison:

The Jostra Flowprobe FP-32E has the same intended use as the Mediconic rate The "Jostra" Trowprobe TT - 62E Tiao" (novembe FP-32E is a 3/8" polycarbonate probe. Diowedicus DF-30 llow probe is a 3/8" acrylic probe is a 3/8" acrylic probe. Comparative The Medifornic BioMedicas Dr oc them probo is a mot affect safety and effectiveness.

Non-Clinical Testing:

Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.

> ゃ.m.ma=a===================================================================================================================================================================== Prepared by Jostra AG, Hirrlingen, Germany

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Performance testing included:

Functional testing Flow measurement accuracy Pressure testing Electrical safety

Additionally, in-vitro testing was performed to determine the effects on cellular components.

Conclusion:

Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is Performance, and in-vitro testing demonstrate device in intended use, principles of operation, materials, design, and performance.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a series of flowing lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 1 4 2001

Jostra AG c/o Mr. Ned E. Devine, Jr. Entala, Inc. 3033 Madison Avenue SE Grand Rapids, MI 49548

Re: K013939

Trade Name: Jostra Flowprobe FP-32E Regulation Number: 21 CFR 870.2120 Regulation Name: Extravascular Blood-Flow Probe Regulatory Class: Class II (two) Product Code: DPT Dated: October 15, 2001 Received: November 29, 2001

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conninered price to ria) 2011-11-11 in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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.

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 may or subject to back as a substions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Ned E. Devine, Jr.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advisou that I Dr b issual.re syour device complies with other requirements of the Act that I Dri has made a averalations administered by other Federal agencies. You must or any I coloral statutes and reguirements, including, but not limited to: registration and listing (21 Comply with an the Hot 8 requirements) and manufacturing practice requirements as set Of K Part 677, lacemig (21 CFR Part 820); and if applicable, the electronic fordint me quanty Bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and hy July finding of substantial equivalence of your device to a legally promated notifications on "ceresults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally at [phone]. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mistmances, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Katy Tell

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Flowprobe FP-32E

## Indications for Use:

,第二次

- 2017-01-1

1 . . . . . . The Jostra Flowprobe FP-32E is indicated for use as a flow measuring device to be The bootra Flowprobot an electromagnetic blood flow transducer as a direct product asos in ochjanomic BioMedicus flowprobe DP-38 in extracorporeal circuits for up to 6 hours.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number R013159

(Optional Format 3-10-98)

**Prescription Use**
(Per 21 CFR 801.109)