(66 days)
The V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal circuit to provide a volume reservoir, compliance, and assist in removing air during the vacuum assisted venous drainage operating mode.
Not Found
- Acceptance Criteria and Reported Device Performance:
The provided document does not contain explicit acceptance criteria and corresponding reported device performance metrics in a tabular format. The document is a 510(k) clearance letter, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
- Sample Size for Test Set and Data Provenance:
The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) because it is a 510(k) clearance letter, not a clinical study report. Such details would typically be found in a separate submission, often summarized in the "substantial equivalence" section or a specific performance testing report.
- Number of Experts and Qualifications for Ground Truth Establishment:
The document does not mention the number of experts used or their qualifications for establishing ground truth for any test set. This information is not typically part of a 510(k) clearance letter for a device like this, which is a physical medical device (blood reservoir) rather than an AI/software device that requires human interpretation for ground truth.
- Adjudication Method for Test Set:
The document does not specify any adjudication method for a test set. This is not applicable given the nature of the device and the content of the 510(k) clearance letter.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is usually relevant for diagnostic imaging or AI devices where human reader performance is compared with and without AI assistance. This device (V-Bag and Vac-Box) is a cardiopulmonary bypass blood reservoir, not a diagnostic or AI-powered interpretative tool.
- Standalone (Algorithm Only) Performance Study:
The document does not mention a standalone (algorithm only) performance study. This is not applicable as the device is a physical medical device, not an algorithm.
- Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. For a physical device like a blood reservoir, ground truth would typically refer to objective measurements of device performance, such as volume capacity, air removal efficiency, biocompatibility, and structural integrity, against predefined engineering specifications and international standards. This information would be found in design verification and validation testing reports, not typically detailed in a 510(k) summary letter.
- Sample Size for Training Set:
The document does not mention a sample size for a training set. This concept (training set) is relevant for machine learning or AI models, which is not applicable to the V-Bag and Vac-Box described.
- How Ground Truth for Training Set Was Established:
The document does not mention how ground truth for a training set was established, as it is not applicable to this physical medical device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird with three wing-like shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 5 2001
Mr. Yehuda Tamari President Circulatory Technology Inc. 21 Singworth Street Oyster Bay, NY 11771
Re: K012942
Trade Name: The V-Bag and Vac-Box for Vacuum Assisted Venous Drainage Regulation Number: 21 CFR 870.4400 Regulation Name: Cardiopulmonary bypass blood reservoir Regulatory Class: II (two) Product Code: DTN Dated: August 30, 2001 Received: August 31, 2001
Dear Mr. Tamari
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 - Mr. Yehuda Tamari
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r todo oo actives made a determination that your device complies with other requirements of the Act or that I Dr. I has mutes 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 labeling (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 premailed nodicate 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 additionally 21 (301) 594-4646. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-4639 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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KD129442 Page A10-1
Attachment 10 V-Bag™ and Vac-Box™ for VAVD Indications for Use
510(k) Number Device Name: Indications for Use: K01_294 レ V-Bag™ with the Vac-Box™ V-Bag™ with the Vac-Box™ are designed for use in an extracorporeal The V-Dag - und the vac Doservoir, compliance, and assist in removing air cheun to provide a volume rose. For, occar, or vacuum assisted venous drainage operating mode.
NOV 0 5 2001
Division of Cardiovascular & Respiratory Devices
510(k) Number K012947
§ 870.4400 Cardiopulmonary bypass blood reservoir.
(a)
Identification. A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.(b)
Classification. Class II (special controls), except that a reservoir that contains a defoamer or filter is classified into the same class as the defoamer or filter. The device, when it is a cardiopulmonary bypass blood reservoir that does not contain defoamers or blood filters, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.