PERIVAC KIT, MODELS 4304, 4305, 4314, 4315

K040867 · Boston Scientific Corp · DQX · Apr 30, 2004 · Cardiovascular

Device Facts

• Record ID: K040867
• Device Name: PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
• Applicant: Boston Scientific Corp
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

PeriVac Kit is a pre-assembled, single-use convenience kit containing 21 components for emergency pericardial aspiration and drainage. Components include needles, guidewire, dilator, and catheter for site preparation, anesthesia, puncture, and fluid collection. Used in clinical settings (Special Procedures Laboratory, Cardiac Catheterization Laboratory, or bedside) by trained physicians. Procedure involves entering the pericardium via progressively larger needles, guidewire, dilator, and catheter; fluid is drained into a graduated bag. Catheter is withdrawn and entry site closed upon completion. Kit facilitates rapid initiation of drainage to relieve tamponade. Output is the physical removal of pericardial fluid. Benefits include convenience, reduced preparation time, and standardized equipment for emergency cardiac procedures.

Clinical Evidence

Bench testing only. Non-clinical tests conducted showed the device met its design-input criteria and was safe and effective for its intended use. No clinical data provided.

Technological Characteristics

Convenience kit containing 21 components for pericardial access. Single-use, sterile (ETO), non-pyrogenic. Includes needles, guidewire, dilator, and catheter. No power source. Packaging consists of thermoform tray, CSR wrap, and header pouch. 2-year expiration.

Indications for Use

Indicated for patients requiring pericardial aspiration and drainage due to pericardial effusion or tamponade.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Mansfield Kit (Pre-Amendment)

Reference Devices

• PeriVac Kit (K032050)

Submission Summary (Full Text)

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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: [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |
| 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 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.

## 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.

OR

#### 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) Reference<br>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<br>intended for use in pericardial<br>aspiration and drainage in the<br>presence of pericardial effusion<br>or tamponade. | The Pericardiocentesis Kit is<br>intended for use in pericardial<br>aspiration and drainage in the<br>presence of pericardial effusion<br>or tamponade. | The Pericardiocentesis Kit is<br>intended for use in pericardial<br>aspiration and drainage in the<br>presence of pericardial effusion or<br>tamponade. |
| Anatomical Sites | Pericardium | Pericardium | Pericardium |
| Method of Use | The Pericardium is entered via a<br>series of progressively larger<br>positioning of needles,<br>guidewire, dilator, and catheter<br>positioning. Once confirmed in<br>position, fluid contained in the<br>pericardium is drained into a<br>graduated bag. Upon completion<br>the catheter is withdrawn and<br>the entry site closed. | The Pericardium is entered via a<br>series of progressively larger<br>positioning of needles,<br>guidewire, dilator, and catheter<br>positioning. Once confirmed in<br>position, fluid contained in the<br>pericardium is drained into a<br>graduated bag. Upon completion<br>the catheter is withdrawn and<br>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<br>(years) | Two year | One year | Two year |
| Single Use Only | Yes | Yes | Yes |
| Packaging | Thermoform Tray, Wrapped in<br>CSR Wrap, and sealed in<br>Header Pouch | Thermoform Tray, Wrapped in<br>CSR Wrap, and sealed in<br>Header Pouch | Thermoform Tray, Wrapped in<br>CSR Wrap, and sealed in<br>Header Pouch |
| Packaging Contents | The 21 components provided in<br>the PeriVac Kit are presented in<br>Table 4. | The 17 components provided in<br>the Mansfield kit are presented<br>on the product label (Appendix<br>D). | The 21 components provided in<br>the PeriVac Kit are presented in<br>Table 4. |
| Contraindications | There are no known<br>contraindications for pericardial<br>aspiration, although recurrent<br>effusion or unresolved<br>tamponade may warrant surgical<br>intervention. | There are no known<br>contraindications for pericardial<br>aspiration, although recurrent<br>effusion or unresolved<br>tamponade may warrant surgical<br>intervention. | There are no known<br>contraindications for pericardial<br>aspiration, although recurrent<br>effusion or unresolved<br>tamponade may warrant surgical<br>intervention. |
| | | | |
| Warnings and Precautions | Inspect all devices and<br>equipment prior to use. Ensure that sterile barrier has<br>not been breached. Careful attention to aseptic<br>technique should be<br>employed. This kit should be used only by<br>persons thoroughly trained in<br>the techniques of pericardial<br>centesis. Take proper care to ensure<br>that patient-contact electrical<br>equipment is properly isolated<br>and grounded. STERILE. For one procedure<br>only. Do not resterilize. CT scan, fluoroscopic, or<br>echocardiographic<br>examinations are<br>recommended to evaluate<br>needle and catheter<br>placement. Pericardiocentesis should be<br>carried out in the Special<br>Procedures Laboratory or<br>Cardiac Catherization<br>Laboratory, utilizing equipment<br>capable of cardiac monitoring.<br>When performed at bedside,<br>electrocardiographic<br>monitoring should be<br>employed continuously. | Inspect all devices and<br>equipment prior to use. Take<br>proper care to ensure that all<br>patient-contact electrical<br>equipment is properly isolated<br>and grounded. Do not wipe<br>catheter with organic solvents<br>(e.g. alcohol, ethers, esters,<br>phenols, etc.). Careful<br>attention to aseptic technique<br>should be employed. | Inspect all devices and<br>equipment prior to use. Ensure that sterile barrier has<br>not been breached. Careful attention to aseptic<br>technique should be<br>employed. This kit should be used only by<br>persons thoroughly trained in<br>the techniques of pericardial<br>centesis. Take proper care to ensure<br>that patient-contact electrical<br>equipment is properly isolated<br>and grounded. STERILE. For one procedure<br>only. Do not resterilize. CT scan, fluoroscopic, or<br>echocardiographic<br>examinations are<br>recommended to evaluate<br>needle and catheter<br>placement. Pericardiocentesis should be<br>carried out in the Special<br>Procedures Laboratory or<br>Cardiac Catherization<br>Laboratory, utilizing equipment<br>capable of cardiac monitoring.<br>When performed at bedside,<br>electrocardiographic<br>monitoring should be<br>employed continuously. Replace the straight catheter<br>with pigtail catheter (sold<br>separately) if drainage is<br>required for up to 24 hours. Do<br>not leave the pigtail catheter in<br>longer than 24 hours. Secure the pigtail catheter to<br>the skin and apply a sterile<br>dressing. At the time of catheter |
| Boston Scientific Corporation<br>Special 510(k) Submission | | CONFIDENTIAL | |

- 12 -Boston Scientific Corporation

Special 510(k) Submission

CONFIDENTIAL

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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

13

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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 [phone]

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 [phone]. 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 [phone] or [phone], 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