(83 days)
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Jostra Vent Catheter:
The provided 510(k) summary for the Jostra Vent Catheter (K022022) focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific quantitative acceptance criteria or detailing a comprehensive study with the elements typically found in AI/ML device submissions.
Therefore, the requested information elements related to AI/ML device studies (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI) are not applicable to this traditional medical device submission.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate Device Performance) | Reported Device Performance (Jostra Vent Catheter) |
|---|---|---|
| Biocompatibility | Equivalent biocompatibility to predicate devices. | Biocompatibility testing performed and deemed equivalent. |
| Kink Stability | Equivalent kink stability to predicate devices. | Kink stability testing performed on smallest and largest models; deemed equivalent. |
| Leak Testing | Equivalent leak integrity to predicate devices. | Leak testing performed on smallest and largest models; deemed equivalent. |
| Tensile Strength | Equivalent tensile strength to predicate devices. | Tensile strength testing performed on smallest and largest models; deemed equivalent. |
| Effects on Cellular Components | No adverse effects on cellular components beyond that of predicate devices. | In-vitro testing performed to determine effects on cellular components; deemed equivalent. |
| Design Dimensions (French size) | Within acceptable range for intended use; comparable to predicate devices. | Range from 8 to 18 French. (Predicate devices: Medtronic DLP 10-20 Fr, Edwards Lifesciences 20 Fr). Differences did not affect safety/effectiveness. |
| Design Dimensions (Length) | Within acceptable range for intended use; comparable to predicate devices. | Range from 23 to 40 cm. (Predicate devices: Medtronic DLP 33 & 41 cm, Edwards Lifesciences 36.8 cm). Differences did not affect safety/effectiveness. |
| Intended Use | Same intended use as predicate devices. | Used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less. (Same as predicates). |
| Materials | Similar materials to predicate devices. | Made of polyvinyl chloride. (Implicitly similar to predicates). |
| Principles of Operation | Same principles of operation as predicate devices. | (Implicitly same as predicates). |
Note: The acceptance criteria are implicitly derived from the performance and characteristics of the legally marketed predicate devices. The study's goal was to demonstrate "substantial equivalence" of the Jostra Vent Catheters to these predicates, meaning its performance, safety, and effectiveness are comparable.
2. Sample size used for the test set and the data provenance
- Sample Size: The document mentions "Performance testing of the smallest and largest models" and "in-vitro testing." It does not specify the exact number of units tested for each parameter (kink stability, leak, tensile strength) or the specific number of in-vitro samples.
- Data Provenance: Not specified. Given it's a submission by a German company (Jostra AG) to the US FDA, the testing likely occurred at the manufacturer's facilities or a contract lab, but the country of origin of the data itself is not detailed. The testing is non-clinical/bench testing, not patient data, so "retrospective or prospective" is not applicable in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a mechanical medical device (catheter), not an AI/ML diagnostic tool. There is no concept of "ground truth" established by experts for its performance tests (kink stability, leak, tensile strength). These are objective engineering measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is not an AI/ML diagnostic or image-based device requiring expert adjudication. The tests performed are objective, measurable physical properties.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a component used in surgery; it does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Objective Measurement. For the performance tests (kink stability, leak, tensile strength), the "ground truth" or reference is based on established engineering standards and the performance of the predicate devices, measured objectively. For biocompatibility, it refers to standard biological response evaluations.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or ground truth for such.
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KO22022
510 (K) Summary
| Submitter: | Jostra AGHechinger Straße 3872145 HirrlingenGermany | SEP 11 2002 |
|---|---|---|
| Contact Person: | Kathleen JohnsonP. O. Box 218Oxford, PA 19363Phone: (610) 932-7738Fax: (610) 932-7366 | |
| Date Prepared: | May 29, 2002 | |
| Device Trade Name: | Jostra Vent Catheter | |
| Common/Usual Name: | Cardiac Vent Catheter | |
| Classification Names: | Cardiopulmonary Bypass Vascular Catheter, Cannula andTubing | |
| Predicate Device: | Medtronic DLP Left Heart Vent CathetersEdwards Lifesciences Research Medical Vent Catheters |
Device Description:
The Jostra Vent Catheters are sterile devices for single use only and are not to be resterilized by the user. They are designed for use in venting the left ventricle during cardiopulmonary bypass surgery. The catheter is inserted into the left ventricle via the pulmonary vein, cardiac auricle or cardiac apex. The catheters are made of polyvinyl chloride and are available in a variety of sizes. They are also available in a variety of configurations (straight or bent tip, with or without wire reinforcement, with or without an integrated stylet, with or without a vacuum valve, malleable and non malleable). The catheters range from 8 to 18 French and are offered in lengths from 23 to 40 cm.
Indications for use:
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
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Statement of Technical Characteristics Comparison:
The Jostra Vent Catheters have the same intended use and similar design as the Medtronic DLP and Edwards Lifesciences Research Medical Vent Catheters. The Jostra Vent Catheters range from 8 to 18 French and are 23 to 40 cm in length. The Medtronic DLP Vent Catheters range from 10 to 20 French and are 33 and 41 cm in length. The Edwards Lifesciences Research Medical device is a 20Fr. O.D. and 36.8 cm long. Comparative testing has demonstrated that the differences do not affect safety and effectiveness.
Non-Clinical Testing:
::
Biocompatibility and performance testing was performed to demonstrate substantial equivalency to the predicate device.
Performance testing of the smallest and largest models included:
Kink stability Leak testing Tensile strength testing
Additionally, in-vitro testing was performed to determine the effects on cellular components.
Conclusion:
Performance and in-vitro testing demonstrate that the Jostra Vent Catheters are "substantially equivalent" to the predicate devices in intended use, principles of operation, materials, design, and performance.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, resembling an abstract bird or a symbol representing health and human services.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SFP 1 1 2002
Jostra AG c/o Ms. Kathleen Johnson Regulatory Affairs, Submissions Manager Jostra-Bentley Corporation 478 Media Road Oxford, PA 19363
Re: K022022
Trade Name: Vent Catheters Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWF and DRA Dated: May 29, 2002 Received: June 20, 2002
Dear Ms. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) 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 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.
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Page 2 – Ms. Kathleen Johnson
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 Section 510(k) 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 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 Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact 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 Division of Small Manufacturers, 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,
Dria Plenhu for
Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number:
Device Name: Vent Catheters
Indications for Use
The Jostra Vent Catheters are used to drain blood or fluid from the left ventricle during cardiopulmonary bypass surgery up to 6 hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| FDA/CDRH/ODE/DMC |
|---|
| JUN 205 3 25 PM 02 |
| RECEIVED |
(Optional Format 3-10-98)
Division of Cardiovascular & Respiratory Devices
510(k) Number K022022
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Per 21 CFR 801.109)
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).