The intended use for the PeriVac Kit is as follows: The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion and tamponade.

Device Description

The PeriVac Kit is designed to provide all of the necessary components for site preparation, local anesthesia, puncture, aspiration and/or drainage, collection, and dressing for the completion of pericardial fluid aspiration. The kit is comprised of finished components and packaged to provide convenience for the user. The PeriVac Kit is comprised of 21 components pre-assembled and packaged to eliminate delays when initiating emergency pericardial aspiration of fluid. For customer convenience, the PeriVac Kit will be made available in four packaging configurations with the only difference between the kits being the catheter types and the inclusion of Lidocaine and Providone-Iodine solution. This submission addresses two components of the PeriVac Kit.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the PeriVac Kit, and its comparison to a predicate device. However, it does not contain information regarding acceptance criteria, study design, or performance metrics that would typically be associated with AI/ML device studies. This document is a regulatory submission for a traditional medical device (pericardiocentesis kit), not an AI/ML powered device.

Therefore, I cannot extract the requested information as it is not present in the provided text. The submission focuses on demonstrating substantial equivalence to a predicate device based on device characteristics and intended use, rather than presenting performance data from a clinical or non-clinical study in the context of acceptance criteria.

Summary

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APR 3 0 2004

510(k) Summary of Safety and Effectiveness 3.

General Information a.

Modified Device Information

Category:	Comments:
Sponsor:	Boston Scientific Corporation
	2710 Orchard Parkway
	San Jose, Ca 95134

Correspondent:	Ronald C. Allen, Ph. D.
	Manager, Regulatory Affairs
	Boston Scientific Corporation
	2710 Orchard Parkway
	San Jose, Ca 95134
Contact Information:	E-mail: allenr@bsci.com
	Phone: (408) 895-3670
	Fax: (408) 895-2202
Device Common Name:	Pericardiocentesis Kit
Device Proprietary Name:	PeriVac Kit
Device Classification:	Class II

Predicate Device Information

Predicate Device:	PeriVac Kit
Predicate Device Manufacturer:	Boston Scientific Corporation
Predicate Device Common Name	Pericardiocentesis Kit
Predicate Device Classification:	Class II
Predicate Device Classification Number:	21 CFR $$870.1330$

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b. Date Summary Prepared

March 28, 2004

Description of Device C.

The PeriVac Kit is comprised of 21 components pre-assembled and packaged to eliminate delays when initiating emergency pericardial aspiration of fluid. For customer convenience, the PeriVac Kit will be made available in four packaging configurations with the only difference between the kits being the catheter types and the inclusion of Lidocaine and Providone-Iodine solution. This submission addresses two components of the PeriVac Kit.

d. Intended Use

The intended use for the PeriVac Kit is as follows:

The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion and tamponade.

Comparison to Predicate Device e.

See Table I- Comparison of Device Characteristics to Predicate on the following page.

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Table 1 - Comparison of Device Characteristics to Predicate

	CLEARED KIT	PREDICATE KIT
FEATURE	PeriVac Kit	Mansfield Kit	Current Submission
510(k) ReferenceNumber	K032050	Pre-Amendment
Product Code	DQX	-	DQX
Classification Section	21CFR 870.1330	21CFR 870.1330	21CFR 870.1330
Classification Name	Convenience Kit	Convenience Kit	Convenience Kit
Indications for Use	The Pericardiocentesis Kit isintended for use in pericardialaspiration and drainage in thepresence of pericardial effusionor tamponade.	The Pericardiocentesis Kit isintended for use in pericardialaspiration and drainage in thepresence of pericardial effusionor tamponade.	The Pericardiocentesis Kit isintended for use in pericardialaspiration and drainage in thepresence of pericardial effusion ortamponade.
Anatomical Sites	Pericardium	Pericardium	Pericardium
Method of Use	The Pericardium is entered via aseries of progressively largerpositioning of needles,guidewire, dilator, and catheterpositioning. Once confirmed inposition, fluid contained in thepericardium is drained into agraduated bag. Upon completionthe catheter is withdrawn andthe entry site closed.	The Pericardium is entered via aseries of progressively largerpositioning of needles,guidewire, dilator, and catheterpositioning. Once confirmed inposition, fluid contained in thepericardium is drained into agraduated bag. Upon completionthe catheter is withdrawn andthe entry site closed.	Same
Power Source	None	None	None
Sterilization Method	ETO	ETO	ETO
	CLEARED KIT	PREDICATE KIT
FEATURE	PeriVac Kit	Mansfield Kit	Current Submission
Pyrogen Free	Non-pyrogenic	Non-pyrogenic	Non-pyrogenic
Expiration Date(years)	Two year	One year	Two year
Single Use Only	Yes	Yes	Yes
Packaging	Thermoform Tray, Wrapped inCSR Wrap, and sealed inHeader Pouch	Thermoform Tray, Wrapped inCSR Wrap, and sealed inHeader Pouch	Thermoform Tray, Wrapped inCSR Wrap, and sealed inHeader Pouch
Packaging Contents	The 21 components provided inthe PeriVac Kit are presented inTable 4.	The 17 components provided inthe Mansfield kit are presentedon the product label (AppendixD).	The 21 components provided inthe PeriVac Kit are presented inTable 4.
Contraindications	There are no knowncontraindications for pericardialaspiration, although recurrenteffusion or unresolvedtamponade may warrant surgicalintervention.	There are no knowncontraindications for pericardialaspiration, although recurrenteffusion or unresolvedtamponade may warrant surgicalintervention.	There are no knowncontraindications for pericardialaspiration, although recurrenteffusion or unresolvedtamponade may warrant surgicalintervention.

Warnings and Precautions	Inspect all devices andequipment prior to use. Ensure that sterile barrier hasnot been breached. Careful attention to aseptictechnique should beemployed. This kit should be used only bypersons thoroughly trained inthe techniques of pericardialcentesis. Take proper care to ensurethat patient-contact electricalequipment is properly isolatedand grounded. STERILE. For one procedureonly. Do not resterilize. CT scan, fluoroscopic, orechocardiographicexaminations arerecommended to evaluateneedle and catheterplacement. Pericardiocentesis should becarried out in the SpecialProcedures Laboratory orCardiac CatherizationLaboratory, utilizing equipmentcapable of cardiac monitoring.When performed at bedside,electrocardiographicmonitoring should beemployed continuously.	Inspect all devices andequipment prior to use. Takeproper care to ensure that allpatient-contact electricalequipment is properly isolatedand grounded. Do not wipecatheter with organic solvents(e.g. alcohol, ethers, esters,phenols, etc.). Carefulattention to aseptic techniqueshould be employed.	Inspect all devices andequipment prior to use. Ensure that sterile barrier hasnot been breached. Careful attention to aseptictechnique should beemployed. This kit should be used only bypersons thoroughly trained inthe techniques of pericardialcentesis. Take proper care to ensurethat patient-contact electricalequipment is properly isolatedand grounded. STERILE. For one procedureonly. Do not resterilize. CT scan, fluoroscopic, orechocardiographicexaminations arerecommended to evaluateneedle and catheterplacement. Pericardiocentesis should becarried out in the SpecialProcedures Laboratory orCardiac CatherizationLaboratory, utilizing equipmentcapable of cardiac monitoring.When performed at bedside,electrocardiographicmonitoring should beemployed continuously. Replace the straight catheterwith pigtail catheter (soldseparately) if drainage isrequired for up to 24 hours. Donot leave the pigtail catheter inlonger than 24 hours. Secure the pigtail catheter tothe skin and apply a steriledressing. At the time of catheter
Boston Scientific CorporationSpecial 510(k) Submission		CONFIDENTIAL

12 -Boston Scientific Corporation

Special 510(k) Submission

CONFIDENTIAL

Lagund)

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SPECIAL 510(K) SUBMISSION PeriVac Kit

CONFIDENTIAL

9 30 h (480) 07 100 100 100 100 100 100 100 1000 1000 1000 1000 1000 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Summary of the Non-clinical Data f.

Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.

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Image /page/6/Picture/1 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 an abstract symbol resembling an eagle or bird with three stylized wing segments.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2004

Boston Scientific Corp. c/o Dr. Ronald Allen EP Technologies, Inc. 2710 Orchard Parkway San Jose, CA 95134

Re: K040867

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: March 28, 2004 Received: April 2, 2004

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. Please note: 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, FDA may 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 (OS) 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 drug, 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,

Donna R. Lochner

(1) 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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Premarket Notification -Indication for Use Statement

Device Name: PeriVac Kit

Indication for Use:

The intended use for PeriVac Kit is as follows:

The PeriVac Kit is intended for use in pericardial aspiration and drainage in the presence of pericardial effusion or tamponade.

Prescription Use______________________________________________________________________________________________________________________________________________________________

Over-the-Counter Use_

(Per 21 CFR §801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duana R. Lochner

CHOVE

510(k) Number

Regulation Number and Section

§ 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.