The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.

Device Description

The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Disposable Temporary Pacing Wire" by RIVER Medical, Inc. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with specific acceptance criteria and performance metrics as might be found in a De Novo or PMA submission.

Therefore, many of the requested elements for describing acceptance criteria and a study proving a device meets them are not applicable in this context. The information provided outlines the device's description, intended use, indications for use, and a comparison of technological characteristics to a predicate device, along with the regulations and standards it complies with.

Here's an attempt to address your points based on the provided text, noting where specific information is absent:

1. A table of acceptance criteria and the reported device performance

This information is not explicitly provided in the summary of safety and effectiveness for a 510(k) submission. A 510(k) focuses on demonstrating equivalence to a predicate device, often by showing compliance with recognized standards and design controls, rather than establishing new, specific performance acceptance criteria for the device beyond what the predicate meets. The document lists several standards and regulations that the device and its predicate comply with, which implicitly define acceptable performance within those standards.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not provided. A 510(k) submission primarily relies on comparisons to predicate devices and adherence to recognized standards, rather than new extensive clinical or performance studies with defined test sets and data provenance for demonstrating novel performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not provided. As no specific test set or ground truth establishment process is described, expert involvement for this purpose is not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. No test set or associated adjudication method is described.

5. 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

This information is not applicable and not provided. The device is a "Disposable Temporary Pacing Wire," which is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. There is no mention of a specific ground truth used for validating the device's performance in the context of this 510(k) submission. Device performance is generally inferred from compliance with standards and equivalence to the predicate.

8. The sample size for the training set

This information is not provided. As this is a physical medical device, there wouldn't typically be a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

Summary of what is provided related to device validation/substantiation:

The document emphasizes that the device meets safety and effectiveness requirements by:

Substantial Equivalence: It is substantially equivalent to a legally marketed predicate device.
Material and Design Comparison: The proposed device comprises "the same or similar material" as the predicate device.
Compliance with Standards and Regulations: Both the manufacture and QC testing of the device, and implicitly its performance, are in substantial compliance with numerous recognized standards and regulations, including:
- 21 CFR 898; 62 FR 25497
- USP <871> Sutures - Needle Attachment
- USP <881> Tensile Strength - Surgical sutures
- USP <71> Sterility Tests
- USP <861> Sutures - Diameter
- ANSI/AAMI/ISO 10993-7 (Biocompatibility/Biological Evaluation)
- Various clauses and sub-clauses of IEC 60601-1, IEC 60601-2-27 (Medical electrical equipment - safety and essential performance)
- ANSI/AAMI EC 53 (Pacing System Leads)
- UL 2601; 55

These standards and regulations serve as the de-facto "acceptance criteria" for this type of device in a 510(k) submission, confirming that it meets established safety and performance benchmarks for similar devices on the market. The "study" proving the device meets these criteria is the manufacturing and QC testing processes that demonstrate compliance with these listed standards.

Summary

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JUN 1 1 2003

Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed RIVER Medical RIVER-WIRE component device.

Manufacturer:	RIVER Medical, Inc.836 NE 24th AvenuePortland, OR 97232PHONE: (503) 230-1280FAX: (503) 233-1152
Contact Person:	Mary Ann Greenawalt, Vice PresidentLegal & Regulatory Affairs
Device Name:
Trade Name:	Disposable Temporary Pacing Wire
Common Name:	Component to diagnostic or physiologicalmonitoring devices
Proprietary name:	RIVER Wire™
Classification:	Cable, Transducer and Electrode, Patient (includingConnector), Cardiovascular, LDF, Class II
Date Prepared:	September 19, 2002

Device Description: The proposed device and the predicate device(s) are composed of metallic 28- to 32-gauge wire, an extruded insulation coating, a special curved needle to ease the transcutaneous placement of the electrode in the skin, and a snap-off straight needle. The leads are available in various sizes, lengths, and quantities. The predicate and proposed devices are manufactured in compliance with special controls/performance standards as dictated by 21 CFR 898; 62 FR 25497 26 USP <871> Sutures - Needle Attachment, <881> Tensile Strength - Surgical sutures, <71> Sterility Tests, <861> Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1; Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1. Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6.

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Intended Use: The RIVER Medical Temporary Cardiac Pacing Wire is a nonabsorbable surqical cardiac pacer lead with dual needle intended to be used for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is SINGLE USE ONLY. The device is supplied nonsterile on OEM basis only.
Indications: The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.

Comparison of Technological Characteristics: The proposed device, the disposable temporary pacing wire, comprises the same or similar material as the predicate device. Manufacture of this device, and QC testing, is in substantial compliance with current 21 CFR 898; 62 FR 2549726 USP <871> Sutures - Needle Attachment, <881> Tensile Strength - Surgical sutures. <71> Sterility Tests. <861> Sutures - Diameter. ANSI/AAMI/ISO 10993-7. IEC 60601-1-Sub-Clause 6.1; IEC 601-1, Sub-Clause 4.10; IEC 601-1, Sub-Clause 44.7; IEC 60601-1, Sub-Clause 20.4, IEC 60601-2-27, Clause 20.3 ANSI/AAMI EC 53, Cl. 5.5.1; IEC 60601-1, Sub-Clause 19.4h, ANSI/AAMI EC53, Clause 5.5.2; IEC 60601-1, Cl. 21.5, IEC 60601-2-27, Cl. 21.5, UL 2601; 55; ANSI/AAMI EC53, Clause 5.5.10; IEC 60601-1, Sub-Clause 57.4a, ANSI/AAMI EC 53, Clause 5.5.6.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2003

RIVER Medical, Inc. c/o Ms. Mary Ann Greenawalt Vice President Legal & Regulatory Affairs 836 NE 24th Avenue Portland, OR 97232

Re: K023174

Trade Name: Disposable Temporary Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode. Regulatory Class: Class II (two) Product Code: LDF Dated: April 28, 2003 Received: May 5, 2003

Dear Ms. Greenawalt:

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.

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

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Page 2 - Ms. Mary Ann Greenawalt

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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

NoQalettun
Bram D. Zuckerman, M.D.

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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INDICATIONS FOR USE

510(k) (if known):

K023174

DEVICE Name:

Disposable Temporary Pacing Wire

Indications for Use:

The RIVER Medical Disposable Temporary Cardiac Pacing Wire is indicated for use in temporary atrial and ventricular pacing and sensing during and after cardiac surgery.

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

Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ 510(k) Num

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.