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

Device Description

The proposed device is an accessory to Arrow's existing Percutaneous Sheath Introducer (PSI) (K780532). The adapter is attached to the hemostasis valve of the sheath introducer allowing a broader range of device sizes to be placed through the introducer.

AI/ML Overview

The provided text describes a 510(k) summary for a "Sheath Adapter" and the FDA's clearance letter. This type of device (a catheter Introducer accessory) is a physical medical device and not an AI/ML or imaging device. Therefore, many of the requested categories in the prompt, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "ground truth," "training set," "adjudication method," and "experts," are not applicable.

However, I can still extract information about the acceptance criteria and the study that proves the device meets them based on the provided text.

Here's the breakdown of the information that can be extracted:

Acceptance Criteria and Recorded Device Performance

Acceptance Criteria Category	Reported Device Performance (from "Performance tests")
Leak resistance	Tests were performed to demonstrate substantial equivalence.
Insertion / drag force	Tests were performed to demonstrate substantial equivalence.
Cap torsion	Tests were performed to demonstrate substantial equivalence.

Note: The document states that "Tests were performed to demonstrate substantial equivalence in the following areas," implying that the device's performance in these areas was comparable to the predicate devices and thus met the acceptance criteria by demonstrating this equivalence. The specific quantitative values or thresholds for "acceptance" are not detailed in this summary, nor are the specific results beyond the statement of substantial equivalence.

Study Details (Applicable to Physical Device Clearance)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document mentions "laboratory tests" were performed, but does not specify the sample size for these tests or the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device and not an AI/ML or imaging device that requires expert ground truth. The "ground truth" for a physical device is typically defined by engineering specifications and objective measurements against those specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept is relevant for reconciling discrepancies in expert assessments for AI/ML ground truth, which is not relevant here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI/ML-assisted diagnostic devices, not for a physical shealth adapter.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This concept is relevant for AI/ML algorithms. The performance tests ("Leak resistance," "Insertion / drag force," "Cap torsion") are inherently "standalone" in the sense that they are physical tests of the device itself, without human interpretation of an output like an image.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this physical device, the "ground truth" for the performance tests would be defined by engineering specifications and objective measurements against those specifications for attributes like leak resistance, insertion/drag force, and cap torsion, likely compared to predicate device performance or industry standards. These are not typically established by expert consensus or pathology in the way AI/ML devices require.
The sample size for the training set:
- Not applicable. This concept is relevant for AI/ML devices.
How the ground truth for the training set was established:
- Not applicable. This concept is relevant for AI/ML devices.

Summary

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Special 510(k)

SECTION 3. 510(K) SUMMARY

Submitter:	ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA
Contact person:	Brandon EptingRegulatory AssociatePhone: 610-378-0131, ext. 3498Fax: 610-374-5360Email: brandon.epting@arrowintl.com
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 whichthe device is substantially equivalent:	Arrow Percutaneous Sheath Introducer (K780532)Thomas Medical Products Tuohy-Borst Adapter (K904608)
Description of the device:	The proposed device is an accessory to Arrow's existingPercutaneous Sheath Introducer (PSI) (K780532). Theadapter is attached to the hemostasis valve of the sheathintroducer allowing a broader range of device sizes to beplaced through the introducer.
Intended use of the device:	When attached to the hub of the PSI, a hemostasis valve inthe sheath adapter device permits the insertion of a 4 Fr to7 Fr catheter through the PSI and prevents leaking andbleedback. The Tuohy-Borst mechanism in the sheathadapter can be tightened to prevent catheter migration andto prevent leakage and bleedback.
Technological characteristics:	The proposed sheath adapter has the same technologicalcharacteristics as the predicate devices.
Performance tests:	Tests were performed to demonstrate substantialequivalence in the following areas:• Leak resistance• Insertion / drag force• Cap torsion
Conclusions:	The results of the laboratory tests demonstrate that thedevice is as safe and effective as the legally marketedpredicate 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page

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)

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).