(106 days)
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.
This submission package does not contain the level of detail required to complete the requested table and provide specific information on acceptance criteria and study design elements like sample sizes, ground truth establishment, or expert qualifications. The provided document is a 510(k) summary for a medical device (24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line) seeking substantial equivalence to predicate devices.
Here's why and what can be pieced together:
Key Takeaways from the Document:
- Substantial Equivalence: The primary goal of this submission is to demonstrate that the new device is substantially equivalent to already legally marketed predicate devices. This means it has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.
- No Clinical Trials: 510(k) submissions, especially for devices seeking substantial equivalence based on minor modifications, often rely heavily on bench testing and comparison to predicates rather than extensive clinical studies with human participants. This is evident as no mention of human subject data, clinical trials, or expert reader studies (MRMC, standalone AI performance) is present.
- Bench Testing: The document explicitly states: "The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability."
Therefore, many sections of your request cannot be directly answered from this document.
Here's an attempt to populate the table and answer the questions based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Material Properties | Biocompatibility: Device materials (Polyvinyl Chloride - PVC) must be non-toxic and compatible with biological tissue, similar to predicate devices. | Biocompatibility rationale demonstrated no significant effect on safety and effectiveness when compared to predicate devices. |
| Mechanical Integrity | Kink Resistance: The catheter must maintain patency and functionality when subjected to bending or kinking forces, similar to predicate devices. Clamp Resistance: The catheter must withstand clamping without damage or loss of functionality. Flexibility: The catheter must possess appropriate flexibility for its intended surgical use to facilitate insertion and positioning. Burst Strength: The catheter must withstand internal pressure without bursting. Leak Integrity: The catheter must not leak fluids at connections or along its length. Pull Strength: The catheter must withstand tensile forces during handling and use without separation or damage. | In vitro bench testing (kink, clamp, flexibility, burst, leak, pull testing) demonstrated that the device does not significantly affect safety and effectiveness and is substantially equivalent to predicate devices. |
| Functional Performance | Pressure Monitoring Capability: The integrated pressure monitoring line must accurately and reliably measure left ventricular pressure within an acceptable range, equivalent to predicate devices with pressure monitoring features (e.g., Aortic Root Cannula with Integral Pressure Monitoring Line). | In vitro bench testing included analysis of "pressure monitoring capability," demonstrating substantial equivalence. (Specific performance metrics like accuracy range are not provided in this summary). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the bench tests.
- Data Provenance: The tests are in-vitro bench tests, not involving human or animal subjects. The location of the testing is not specified, but it was conducted by Medtronic, Inc. in the USA. Given the nature of a 510(k) for device modifications, these would be considered retrospective in the sense that the new device's performance is compared against known characteristics or specifications of existing predicate devices and general standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable (N/A) as the study involved in-vitro bench testing, not expert interpretation or clinical assessment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable (N/A) as the study involved in-vitro bench testing, not subjective assessment requiring adjudication.
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 MRMC study was done. This is a 510(k) for a physical medical device (catheter), not an AI-enabled diagnostic tool. Therefore, concerns about human reader improvement with AI are not applicable (N/A).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This is a 510(k) for a physical medical device, not an AI algorithm. Therefore, concerns about standalone algorithm performance are not applicable (N/A).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the bench tests would be the pre-defined engineering specifications, material standards, and performance characteristics of the predicate devices. For instance, the "ground truth" for burst pressure would be a certain pressure threshold the device must withstand, derived from safety standards and predicate device performance. It is based on engineering specifications and established material/device performance standards.
8. The sample size for the training set
- This is not applicable (N/A). This device is not an AI algorithm, and thus, there is no AI "training set."
9. How the ground truth for the training set was established
- This is not applicable (N/A) as there is no AI training set.
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OCT 2 4 2001
APPENDIX III
SUMMARY OF SAFETY AND EFFECTIVENESS TRUTHFUL AND ACCURATE STATEMENT DECLARATION OF CONFORMITY
Special 510(k) Notification 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential Medtronic, Inc. Medtronic Cardiac Surgical Products 7/6/01 18
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SUMMARY OF SAFETY AND EFFECTIVENESS
COMPANY
Medtronic, Inc. Medtronic Cardiac Surgical Products 620 Watson Street S.W. Grand Rapids, MI 49504
CONTACT PERSON
Melissa Harriger Associate Product Requiations Manager Medtronic Cardiac Surgical Products 620 Watson Street SW Tel: 616-643-5519 FAX: 616-643-1017
DEVICE NAME
24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line (12524)
NAME OF PREDICATED OR LEGALLY MARKETED DEVICE
Adult Vent Catheter (K834352) Aortic Root Cannula with Pressure Monitoring Line (K831591)
DESCRIPTION OF DEVICE
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the left heart during cardiopulmonary bypass surgery.
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is equipped with a pressure monitoring line, which allows measurement of left ventricular pressure.
STATEMENT OF INTENDED USE
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for use in venting the left heart during cardiopulmonary bypass surgery.
STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE
The Adult Vent Catheter is intended for use in venting the left heart during cardiopulmonary bypass surgery.
| Special 510(k) Notification | 24 Fr. Left Heart Vent w/ Pressure Monitoring Line Confidential |
|---|---|
| Medtronic, Inc. | |
| Medtronic Cardiac Surgical Products | 7/6/01 |
| 19 |
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STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON
Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence".
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
This "SPECIAL 510(k)" is being submitted for a modification to the Adult Vent Catheter. The modification to the current Adult Vent Catheter is to include a pressure monitoring line and material change
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is being compared to the following Marketed Devices:
- Adult Vent Catheter (K834352) ●
- . Infant Vent Catheter (K834039)
- Aortic Root cannula(s) with Integral Pressure Monitoring Line (K831591) .
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has the same indications statement and intended uses as the:
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line has no new technological characteristics (e.g. materials and manufacturing processes). The technological characteristic of the pressure monitoring line is common to other products in commercial distribution as follows. Additionally, using Polyvinyl Chloride (PVC) is common to other catheter products in distribution, as indicated below in the Infant Vent Catheter.
- Aortic Root Cannula with Integral Pressure Monitoring Line (K831591)
- . Infant Vent Catheter (K834039)
This technological characteristic "could affect the safety and effectiveness of the device". However, this technological characteristic does not raise new types of safety or effectiveness questions. In addition, "there are acceptable scientific methods which exist for assessing effects of this technological characteristic".
"Performance data to assess the effects of this technological characteristic" has been performed. These "performance data demonstrate" that the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is substantially equivalent to other Medtronic marketed cannula.
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The biocompatibility rationale and in vitro bench testing demonstrated that when compared to the predicate devices, the 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line does not significantly affect safety and effectiveness and are substantially equivalent to other commercially distributed devices. The in vitro bench testing included analysis of: kink testing, clamp testing, flexibility testing, burst, leak testing, pull testing and pressure monitoring capability.
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Image /page/4/Picture/2 description: The image is a black and white circular logo. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing to the right. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 4 2001
Ms. Melissa Harriger Associate Product Regulation Manager Medronic Cardiac Surgery 620 Watson SW Grand Rapids, MI 49504
Re: K012143
Trade Name: 24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Steerable Regulatory Class: Class II (two) Product Code: DRA Dated: September 24, 2001 Received: September 25, 2001
Dear Ms. Harriger:
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. Melissa Harriger
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 promated 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,
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number if known: K012143 -
Device Name: 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line
Indications for Use:
The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for venting the left heart during cardiopulmonary bypass surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use
OR
Over-The-Counter use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K012443
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).