(15 days)
The Jostra Flowprobe FP-32E is indicated for use as a flow measuring device to be used as an electromagnetic blood flow transducer as a direct product replacement for the BioMedicus flowprobe DP-38 in extracorporeal circuits for up to 6 hours.
The Jostra Flowprobe FP-32E is a single, sterile device for single use only and not to be re-sterilized by the user. The flowprobe is made from polycarbonate and is available in a 3/8" size.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Jostra Flowprobe FP-32E:
Device Name: Jostra Flowprobe FP-32E
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, it indicates that "performance testing was performed to demonstrate substantial equivalency to the predicate device."
| Acceptance Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|
| Functional testing | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful functional testing. |
| Flow measurement accuracy | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful flow measurement accuracy. |
| Pressure testing | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful pressure testing. |
| Electrical safety | Passed | The conclusion states, "Performance, and in-vitro testing demonstrate that the Jostra Flowprobe FP-32E is... substantially equivalent to the predicate device..." This implies successful electrical safety testing. |
| Biocompatibility | Passed | "Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device." Additionally, "in-vitro testing was performed to determine the effects on cellular components," which supports biocompatibility. |
| Equivalence to Predicate Device (Medtronic-BioMedicus DP-38 Bio-Probe) | Achieved | The overall conclusion is that the device is "substantially equivalent ... in intended use, principles of operation, materials, design, and performance" to the predicate device. The only noted difference is the material (polycarbonate vs. acrylic), which is stated not to affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document only states that "Performance testing included" various types of tests.
- Data Provenance: Not specified, but the submission is from Jostra AG, Germany, so the testing was likely conducted in Germany or by a third-party testing facility. The study is non-clinical (bench testing), not involving human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. This was a non-clinical, bench testing study. Ground truth was established through engineering and performance measurements against established standards or the predicate device's performance.
4. Adjudication Method for the Test Set:
Not applicable. This was a non-clinical, bench testing study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, this was not applicable or done. The study was non-clinical (bench testing) and did not involve human readers or cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical flow probe, not an AI algorithm. Its performance is inherent to its design and function, not dependent on human interpretation or AI.
7. The Type of Ground Truth Used:
The ground truth for the non-clinical testing was based on:
- Engineering specifications and design requirements.
- The established performance characteristics of the predicate device (Medtronic-BioMedicus DP-38 Bio-Probe).
- Industry standards for functional, pressure, electrical safety, and biocompatibility testing for medical devices.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical flow probe and does not involve AI or machine learning that would require a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this device.
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| 510 (K) Summary | DEC 1 4 2001 | K013939 | |
|---|---|---|---|
| Submitter: | Jostra AGHechinger Straße 3872145 HirrlingenGermany | ||
| Contact Person: | Kathleen JohnsonPhone: (610) 932-7738Fax: (610) 932-7366 | ||
| 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-461 the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)
§ 870.2120 Extravascular blood flow probe.
(a)
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.(b)
Classification. Class II (performance standards).