(177 days)
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.
The Medtronic DLP Malleable Single Stage Venous Cannulae represent modified versions of existing Medtronic Single Stage Venous Cannulae. The proposed change involves the incorporation of a malleable wire/tube assembly embedded within the wall of the cannula. This malleable wire/tube assembly allows the cannula body to be shaped into a surgeon preferred position.
The provided document, KO22272 for the Medtronic DLP Malleable Single Stage Venous Cannula, is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing completely new performance criteria. Therefore, the document does not contain detailed acceptance criteria in the form of specific performance metrics or a study that rigorously "proves" the device meets them in the same way a de novo or PMA submission might.
Instead, the acceptance criteria are implicitly met by demonstrating that the new device is as safe and effective as the predicate device, which is already on the market. The study described focuses on non-clinical tests to support this substantial equivalence.
Here's an analysis based on the provided text, addressing the requested points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Biocompatibility (as per ISO 10993-1 for externally communicating devices in contact with circulating blood for <24 hours) | Non-clinical tests conducted, results support assertion of safety and effectiveness as predicate device. |
| Substantial Equivalence to Predicate Device (Medtronic DLP Single Stage Venous Cannulae, K845045) in terms of safety and effectiveness. | The addition of a malleable wire/tube assembly does not change the fundamental scientific technology or intended use. |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary "acceptance criterion" is demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a device already cleared by the FDA. The specific performance metrics are often derived from the predicate device's established safety and effectiveness. Here, the key performance aspect is the biocompatibility of the materials used in the modified device.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the non-clinical tests. "Material biocompatibility was conducted in accordance with the ISO 10993-1 standard," which typically involves various in vitro and in vivo tests, but the number of samples or specimens used is not detailed.
- Data Provenance: The data is from "non-clinical tests" conducted by Medtronic. The country of origin is not explicitly stated, but Medtronic is a US-based company, and the submission is to the FDA. The tests are "non-clinical," meaning they are laboratory or bench tests, not involving human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For non-clinical, biocompatibility testing, "ground truth" is established through standardized laboratory procedures and scientific protocols rather than expert consensus on individual cases.
4. Adjudication method for the test set:
- This concept is not applicable to the type of non-clinical, biocompatibility testing described. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies when multiple human readers/reviewers assess images or clinical outcomes.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a cardiovascular cannula, a physical medical device, not an AI or imaging diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) performance study was not done. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For the non-clinical biocompatibility tests, the "ground truth" is derived from the results of the specific standardized tests themselves (e.g., cytotoxicity assays, sensitization tests, irritation tests, hemocompatibility tests as defined by ISO 10993-1). The pass/fail criteria for these tests, based on established biological responses, serve as the ground truth.
8. The sample size for the training set:
- This device is not an AI/ML algorithm, so there is no "training set" in that sense. The concept of a training set is not applicable.
9. How the ground truth for the training set was established:
- As there is no training set for an AI/ML algorithm, this question is not applicable.
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KO22272
Section 2: 510(k) Summary and Certification
JAN 0 8 2003
510(k) Summary
> Medtronic
Medtronic Cardiac Surgical Products
510(k) Summary [As Required by 21 CFR 807.92]
| Submitter: | Roger BrinkMedtronic Cardiac Surgical Products620 Watson SWGrand Rapids, MI 49504 |
|---|---|
| Telephone: | (616) 643-7337 |
| Fax: | (616) 643-1044 |
| Date Summary Prepared: | July 11, 2002 |
| Trade Name of Device: | Medtronic DLP Malleable Single Stage VenousCannula |
| Common Name of Device: | Cardiovascular cannula |
| Classification Name of Device: | "Cardiopulmonary bypass vascular cannula,"Class II at 21 CFR 870.4210 |
| Predicate SubstantiallyEquivalent Devices: | Medtronic DLP Single Stage Venous Cannulae,Class II at 21 CFR 870.4210, cleared under 510(k)Number K845045 |
| Description of Device: | The Medtronic DLP Malleable Single Stage VenousCannulae represent modified versions of existingMedtronic Single Stage Venous Cannulae. The proposedchange involves the incorporation of a malleable wire/tubeassembly embedded within the wall of the cannula. Thismalleable wire/tube assembly allows the cannula body tobe shaped into a surgeon preferred position. |
| Intended Use of Device: | These cannulae are intended for collection of venousblood from the right side of the heart via the superior andinferior vena cava during cardiopulmonary bypass surgery. |
| Comparison to Existing Predicate Devices | The Medtronic DLP Malleable Single Stage Venous Cannulae are substantiallyequivalent to existing Medtronic DLP Single Stage Venous Cannulae. The existing |
| 510(k) Premarket Submission | Malleable Single Stage Venous CannulaeConfidential |
| Medtronic, Inc. |
7/11/02
6
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cannulae have been modified to include a malleable wire/tube assembly embedded within the cannula body. The indications for use for both the existing and modified devices are identical, and the addition of wire / tube assembly does not represent a change to the fundamental scientific technology of the devices.
Summary of Non-Clinical Performance Data
Material biocompatibility was conducted in accordance with the ISO 10993-1 standard. Under this standard these cannulae are categorized as externally communicating devices in contact with circulating blood for a limited (<24 hour) contact duration.
Conclusions of Non-Clinical Tests
The results of the non-clinical tests summarized above support an assertion that the Medtronic DLP Malleable Single Stage Venous Cannulae are as safe and effective as the existing Medtronic DLP Single Stage Venous Cannulae.
| 510(k) Premarket SubmissionMedtronic, Inc. | Malleable Single Stage Venous Cannulae | Confidential |
|---|---|---|
| Medtronic Cardiac Surgical Products | 7/11/02 | 7 |
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 0 8 2003
Medtronic, Inc. c/o Mr. Roger W. Brink Director, QA/RA Medtronic Cardiac Surgical Products 620 Watson SW Grand Rapids, MI 49504
Re: K022272
Trade Name: Medtronic Malleable Single Stage Venous Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula or Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: October 18, 2002 Received: October 21, 2002
Dear Mr. Brink:
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. Drue, 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 - Mr. Roger W. Brink
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), 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) you may obtain. 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,
KalaTeh
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 (if known): ____________________________________________________________________________________________________________________________________________________
1022272
Device Name: Medtronic Malleable Single Stage Venous Cannulae
Indications for Use:
These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
| 510(k) Number | K022272 |
|---|---|
| --------------- | --------- |
| Prescription Use(Per 21 CFR 801.109) | OR | Ov er-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ----------------------- |
(Optional Format 1-2-96)
| 510(k) Premarket SubmissionMedtronic, Inc. | Malleable Single Stage Venous Cannulae | Confidential |
|---|---|---|
| ------------------------------------------------ | ---------------------------------------- | -------------- |
7/11/02
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Medtronic Cardiac Surgical Products
§ 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).