(211 days)
The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
The Portaclamp™ is a disposable aortic clamping device that is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp™ consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta. and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
The provided text describes a medical device, the Portaclamp™, and its substantial equivalence to predicate devices, but it does not contain the specific information requested in the prompt regarding acceptance criteria and a study that quantitatively proves the device meets those criteria.
Here’s a breakdown of what the document does mention and what is missing:
1. Table of acceptance criteria and the reported device performance
- Missing. The document only states "Information submitted in this premarket notification for the Portaclamp™ includes results of biocompatibility testing, in vitro performance testing, cadaver testing and clinical experience." It does not provide specific acceptance criteria (e.g., "Device must achieve a clamping force of X Newtons") or the corresponding reported performance values.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Missing. The document mentions "cadaver testing and clinical experience" but provides no details on sample size, study design (retrospective/prospective), or data provenance.
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)
- Missing. The concept of "ground truth" as typically applied to AI performance evaluations is not present in this 510(k) summary for a physical medical device like a clamp. Clinical evaluations for such devices typically focus on safety and effectiveness outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Missing. Not applicable to this type of device submission as it doesn't involve subjective assessment of images or data by multiple experts for 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
- Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Missing. As mentioned above, the concept of "ground truth" as related to AI/diagnostic performance is not applicable here. Performance is typically assessed through measures like successful clamping, absence of tissue damage, durability, etc.
8. The sample size for the training set
- Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Missing. This is entirely inapplicable as the Portaclamp™ is a physical surgical device, not an AI algorithm that requires a training set.
In summary, the provided 510(k) summary for the Portaclamp™ is a regulatory document focused on demonstrating substantial equivalence to existing predicate devices. It mentions various types of testing (biocompatibility, in vitro, cadaver, clinical experience) but does not delve into the detailed quantitative performance metrics, acceptance criteria, sample sizes, or expert adjudication methods that would be relevant for evaluating the performance of an AI/diagnostic device as requested in the prompt.
{0}------------------------------------------------
510(k) Summary Cardio Life Research Portaclamp™
1. SPONSOR
Cardio Life Research, s.a. Rue De Clairvaux 40/203 B 1348 Louvain La Neuve Belgium
Contact : Michel Joie Phone: +32 10 480 492
Date Prepared: September 26. 2003
2. DEVICE NAME
| Proprietary Name: | Portaclamp™ |
|---|---|
| Common/Usual Name: | Aortic clamp |
| Classification Name: | Vascular clamp |
3. PREDICATE DEVICES
- Cosgrove Vascular Clamp (K974769) .
- . Heartport Cable Bulldog Clamp (K962366)
- Heartport Endoaortic Clamp (K955132) .
4. DEVICE DESCRIPTION
The Portaclamp™ is a disposable aortic clamping device that is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp™ consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta. and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.
{1}------------------------------------------------
5. INTENDED USE
The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Portaclamp™System is substantially equivalent to other predicate vascular clamps that are used for aortic clamping during cardiac surgery. The Portaclamp™ and the predicate devices have fundamentally the same indications for use. All of these devices are designed to be used to temporarily clamp vessels during surgical procedures. such as the aorta during cardiac surgery.
PERFORMANCE TESTING 7.
Information submitted in this premarket notification for the Portaclamp™ includes results of biocompatibility testing, in vitro performance testing, cadaver testing and clinical experience.
{2}------------------------------------------------
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three horizontal lines that curve upwards, resembling a stylized human form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2004
Cardio Life Research, S.A. c/o Mr. James R. Veale Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K033085
Portaclamp™ Aortic Clamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: DXC Dated: March 2, 2004 Received: March 3, 2004
Dear Mr. Veale:
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.
{3}------------------------------------------------
Page 2 - Mr. James R. Veale
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) 594-4648. 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 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,
Duma R. Lochner
Gram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): K033085
Device Name: Portaclamp™
Indications For Use:
The Portaclamp™ is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwna R. Lochner
Division Sign-Off) Tivision I Cardiovascular Devices
10(k) Number_K033085
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).