SHEATH ADAPTER, MODEL SA-09847

K021723 · Arrow Intl., Inc. · DYB · Aug 8, 2002 · Cardiovascular

Device Facts

• Record ID: K021723
• Device Name: SHEATH ADAPTER, MODEL SA-09847
• Applicant: Arrow Intl., Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

When attached to the hub of the PSI, a hemostasis valve in the sheath adapter device permits the insertion of a 4 Fr to 7 Fr catheter through the PSI and prevents leaking and bleedback. The Tuohy-Borst mechanism in the sheath adapter can be tightened to prevent catheter migration and to prevent leakage and bleedback.

Device Story

Accessory to Percutaneous Sheath Introducer (PSI); attaches to PSI hub. Features hemostasis valve and Tuohy-Borst mechanism. Allows insertion of 4 Fr to 7 Fr catheters through PSI; prevents leaking and bleedback; prevents catheter migration. Used by clinicians in clinical settings to facilitate venous access and catheter introduction.

Clinical Evidence

Bench testing only. Performance tests included leak resistance, insertion/drag force, and cap torsion to demonstrate substantial equivalence.

Technological Characteristics

Mechanical sheath adapter featuring a hemostasis valve and Tuohy-Borst tightening mechanism. Designed for attachment to Percutaneous Sheath Introducer hubs. No electronic or software components.

Indications for Use

Indicated for use in conjunction with one-piece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Arrow Percutaneous Sheath Introducer (K780532)
• Thomas Medical Products Tuohy-Borst Adapter (K904608)

Submission Summary (Full Text)

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## Special 510(k)

# SECTION 3. 510(K) SUMMARY

| Submitter: | ARROW International, Inc.<br>2400 Bernville Road<br>Reading, PA 19605-9607 USA |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Brandon Epting<br>Regulatory Associate<br>Phone: [phone], ext. 3498<br>Fax: [phone]<br>Email: [e-mail] |
| Date summary prepared: | May 20, 2002 |
| Device trade name: | Sheath Adapter |
| Device common name: | Sheath Adapter |
| Device classification name: | Catheter Introducer |
| Legally marketed devices to which<br>the device is substantially equivalent: | Arrow Percutaneous Sheath Introducer (K780532)<br>Thomas Medical Products Tuohy-Borst Adapter (K904608) |
| Description of the device: | The proposed device is an accessory to Arrow's existing<br>Percutaneous Sheath Introducer (PSI) (K780532). The<br>adapter is attached to the hemostasis valve of the sheath<br>introducer allowing a broader range of device sizes to be<br>placed through the introducer. |
| Intended use of the device: | When attached to the hub of the PSI, a hemostasis valve in<br>the sheath adapter device permits the insertion of a 4 Fr to<br>7 Fr catheter through the PSI and prevents leaking and<br>bleedback. The Tuohy-Borst mechanism in the sheath<br>adapter can be tightened to prevent catheter migration and<br>to prevent leakage and bleedback. |
| Technological characteristics: | The proposed sheath adapter has the same technological<br>characteristics as the predicate devices. |
| Performance tests: | Tests were performed to demonstrate substantial<br>equivalence in the following areas:<br>• Leak resistance<br>• Insertion / drag force<br>• Cap torsion |
| Conclusions: | The results of the laboratory tests demonstrate that the<br>device is as safe and effective as the legally marketed<br>predicate devices. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the upper portion of the circle.

Public Health Service

AUG 0 8 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arrow International, Inc. c/o Mr. Brandon Epting Regulatory Affairs Associate 2400 Bernville Road Reading, PA 19605

Re: K021723

Trade Name: Sheath Adapter Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer, Catheter Regulatory Class: Class II (two) Product Code: DYB Dated: July 25, 2002 Received: July 26, 2002

#### Dear Mr. Epting:

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. Brandon Epting

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. 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 (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dea. Tortell

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 7. INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name:

K021723

Sheath Adapter

Indications for Use:

The Arrow Sheath Adapter is utilized in conjunction with onepiece Percutaneous Sheath Introducer to permit venous access and catheter introduction into the central circulation.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K021723

**Prescription Use**
(Per 21 CFR 801.109)