K Number

Device Name

PERIVAC KIT, MODELS 4304, 4305, 4314, 4315

Manufacturer

BOSTON SCIENTIFIC CORP.

Date Cleared

2004-04-30

(28 days)

Product Code

DQX

Regulation Number

870.1330

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

K032050

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical components and intended use for pericardial aspiration and drainage, with no mention of AI or ML capabilities.

Therapeutic

Yes.
The device is used for pericardial aspiration and drainage, which are medical procedures to remove fluid from around the heart to treat conditions like pericardial effusion and tamponade.

Diagnostic

The device description indicates that the PeriVac Kit is used for pericardial aspiration and drainage, which are interventional procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description explicitly states the PeriVac Kit is comprised of 21 physical components for a medical procedure, indicating it is a hardware-based medical device kit, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the PeriVac Kit is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for "pericardial aspiration and drainage in the presence of pericardial effusion and tamponade." This describes a procedure performed directly on the patient's body to remove fluid.
Device Description: The description details components used for site preparation, anesthesia, puncture, aspiration, drainage, collection, and dressing. These are all tools for a medical procedure, not for testing samples in vitro (outside the body).
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing a sample in vitro to provide diagnostic information.

IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The PeriVac Kit is a surgical/procedural kit used to perform a medical intervention.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

DQX

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Pericardium

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K032050

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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$

b. Date Summary Prepared

March 28, 2004

Description of Device C.

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.

Table 1 - Comparison of Device Characteristics to Predicate

	CLEARED KIT	PREDICATE KIT
FEATURE	PeriVac Kit	Mansfield Kit	Current Submission
510(k) Reference
Number	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 is
intended for use in pericardial
aspiration and drainage in the
presence of pericardial effusion
or tamponade.	The Pericardiocentesis Kit is
intended for use in pericardial
aspiration and drainage in the
presence of pericardial effusion
or tamponade.	The Pericardiocentesis Kit is
intended for use in pericardial
aspiration and drainage in the
presence of pericardial effusion or
tamponade.
Anatomical Sites	Pericardium	Pericardium	Pericardium
Method of Use	The Pericardium is entered via a
series of progressively larger
positioning of needles,
guidewire, dilator, and catheter
positioning. Once confirmed in
position, fluid contained in the
pericardium is drained into a
graduated bag. Upon completion
the catheter is withdrawn and
the entry site closed.	The Pericardium is entered via a
series of progressively larger
positioning of needles,
guidewire, dilator, and catheter
positioning. Once confirmed in
position, fluid contained in the
pericardium is drained into a
graduated bag. Upon completion
the catheter is withdrawn and
the 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 in
CSR Wrap, and sealed in
Header Pouch	Thermoform Tray, Wrapped in
CSR Wrap, and sealed in
Header Pouch	Thermoform Tray, Wrapped in
CSR Wrap, and sealed in
Header Pouch
Packaging Contents	The 21 components provided in
the PeriVac Kit are presented in
Table 4.	The 17 components provided in
the Mansfield kit are presented
on the product label (Appendix
D).	The 21 components provided in
the PeriVac Kit are presented in
Table 4.
Contraindications	There are no known
contraindications for pericardial
aspiration, although recurrent
effusion or unresolved
tamponade may warrant surgical
intervention.	There are no known
contraindications for pericardial
aspiration, although recurrent
effusion or unresolved
tamponade may warrant surgical
intervention.	There are no known
contraindications for pericardial
aspiration, although recurrent
effusion or unresolved
tamponade may warrant surgical
intervention.

Warnings and Precautions	Inspect all devices and
equipment prior to use. Ensure that sterile barrier has
not been breached. Careful attention to aseptic
technique should be
employed. This kit should be used only by
persons thoroughly trained in
the techniques of pericardial
centesis. Take proper care to ensure
that patient-contact electrical
equipment is properly isolated
and grounded. STERILE. For one procedure
only. Do not resterilize. CT scan, fluoroscopic, or
echocardiographic
examinations are
recommended to evaluate
needle and catheter
placement. Pericardiocentesis should be
carried out in the Special
Procedures Laboratory or
Cardiac Catherization
Laboratory, utilizing equipment
capable of cardiac monitoring.
When performed at bedside,
electrocardiographic
monitoring should be
employed continuously.	Inspect all devices and
equipment prior to use. Take
proper care to ensure that all
patient-contact electrical
equipment is properly isolated
and grounded. Do not wipe
catheter with organic solvents
(e.g. alcohol, ethers, esters,
phenols, etc.). Careful
attention to aseptic technique
should be employed.	Inspect all devices and
equipment prior to use. Ensure that sterile barrier has
not been breached. Careful attention to aseptic
technique should be
employed. This kit should be used only by
persons thoroughly trained in
the techniques of pericardial
centesis. Take proper care to ensure
that patient-contact electrical
equipment is properly isolated
and grounded. STERILE. For one procedure
only. Do not resterilize. CT scan, fluoroscopic, or
echocardiographic
examinations are
recommended to evaluate
needle and catheter
placement. Pericardiocentesis should be
carried out in the Special
Procedures Laboratory or
Cardiac Catherization
Laboratory, utilizing equipment
capable of cardiac monitoring.
When performed at bedside,
electrocardiographic
monitoring should be
employed continuously. Replace the straight catheter
with pigtail catheter (sold
separately) if drainage is
required for up to 24 hours. Do
not leave the pigtail catheter in
longer than 24 hours. Secure the pigtail catheter to
the skin and apply a sterile
dressing. At the time of catheter
Boston Scientific Corporation
Special 510(k) Submission		CONFIDENTIAL

12 -Boston Scientific Corporation

Special 510(k) Submission

CONFIDENTIAL

Lagund)

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

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.

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.

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.

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

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