(37 days)
The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion or tamponade.
The PeriVac Kit is a complete procedure tray for the purpose or pericardial aspiration and/or drainage. It contains the necessary components for site preparation, anesthesia, puncture, drainage, collection, and dressing.
This 510(k) premarket notification for the PeriVac Kit does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The submission is a substantial equivalence determination, which means the manufacturer is asserting that their device is as safe and effective as a legally marketed predicate device. This type of submission relies on demonstrating similarity to an already approved device rather than presenting new clinical study data with specific acceptance criteria typically seen for novel devices or those with higher risk classifications.
Here's a breakdown of why the requested information isn't available in this document:
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Acceptance Criteria and Reported Device Performance: Not present. The submission focuses on comparing the "Modified Device" (PeriVac Kit) to a "Predicate Device" (Mansfield PeriVac Kit) in terms of intended use, description, single-use nature, sterilization method, manufacturer, and device classification. It doesn't present technical performance metrics or targets.
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Sample Size and Data Provenance for Test Set: Not applicable. No test set for performance evaluation is described.
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Number and Qualifications of Experts for Ground Truth: Not applicable. No ground truth establishment discussed.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not an AI or imaging device where MRMC studies are typically performed.
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Standalone Performance Study: Not applicable. The device is a medical kit for a procedure, not a standalone algorithm or diagnostic tool.
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Type of Ground Truth Used: Not applicable.
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Sample Size for Training Set: Not applicable. This is not a machine learning device.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document is a 510(k) summary for a medical device kit, not a study evaluating performance against specific acceptance criteria. The FDA's determination of substantial equivalence (as shown in the attached letters) is based on the comparison to a predicate device, not on new clinical performance data for the PeriVac Kit itself.
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K032050 pg 1 of 2
AUG - 8 2003
510(k) Notification PeriVac Kit
510(K) SUMMARY
| Category: | Comments |
|---|---|
| Sponsor: | Boston Scientific Corporation/EP Technologies, Inc.2710 Orchard ParkwaySan Jose, CA 95134 |
| Correspondent: | Ronald C. Allen, Ph.,D.Manager, Regulatory Affairs2710 Orchard ParkwaySan Jose, CA 95134 |
| Contact Numbers: | Phone: 408.895.3670Fax: 408.895.2202Email: allenr@bsci.com |
| Device Common Name | Pericardiocentesis Kit |
| Device Proprietary Name | PeriVac Kit |
| Device Classification | Class II |
| Predicate Device | Manfield PeriVac Kit |
| Predicate Device Manufacturer(s) | Mansfield, Boston Scientific Corporation |
| Predicate Device Proprietary Name(s) | Pericardiocentesis Kit |
| Predicate Device Classification(s) | Class II |
Date Summary Was Prepared:
May 3, 2003.
Description of the Device:
The PeriVac Kit is a complete procedure tray for the purpose or pericardial aspiration and/or drainage. It contains the necessary components for site preparation, anesthesia, puncture, drainage, collection, and dressing.
Intended Use:
The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion or tamponade.
Comparison to Predicate Devices:
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | Pre-Amendment- Class II | TBD |
| Intended Use | Pericardial aspiration | Same |
| Device Description | Procedural Kit | Same |
| Single Use? | Yes | Same |
CONFIDENTIAL
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KQ32Q50 pg 20f 2
510(k) Notification
PeriVac Kit
:
| Predicate Device | Modified Device | |
|---|---|---|
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/ EP Technologies | Same |
| DeviceClassification | Class I | Same |
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Public Health Service
Image /page/2/Picture/2 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 symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.
AUG - 8 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corp. c/o Dr. Ronald Allen EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134
Re: K032050
PeriVac Kit, models 4304, 4305, 4314, and 4315 Regulation Number: 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: June 30, 2003 Received: July 2, 2003
Dear Dr. Allen:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
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Page 2 – Dr. Ronald Allen
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to 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. FIDA mav publish further announcements concerning your device in the Federal Register.
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.
In addition, we have determined that your device kit contains 5 ml of 1% HCL Lidocaine which are subject to regulation as a drug.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing this drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101
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, please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled. "Misbranding by reference to premarket notification'(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers,
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Page 3 – Dr. Ronald Allen
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/dsma/dsmamain.html
Sincerely yours,
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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KO32050 510(k) Noufication PeriVac Kit
INTENDED USE STATEMENT
510(k) Number:
PeriVac Kit Device Name:
Indication for Use:
The intended use of the subject kit remains the same as the pre-Amendment kit, and reads as follows:
The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion or tamponade.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED
Qehta
510(k) Number K032050
Prescription Use Only
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.