These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

Device Description

AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM). The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

AI/ML Overview

This document describes the 510(k) summary for Pulse Oximeter Adapter Cables from American IV Products, Inc. The submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, focusing on key characteristics like intended use, construction, and performance. The "reported device performance" reflects that these criteria have been met through testing and comparison.

Acceptance Criteria (Comparison to Predicate Device)	Reported Device Performance
Intended Use: Connects OEM pulse oximeter sensor with OEM monitor for continuous, non-invasive SpO2 and pulse rate monitoring.	Same as predicate devices. The AIV adapter cable connects the OEM pulse oximeter sensor with the OEM monitor for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Type of Construction: Flexible, shielded, multi-conductor electrical cable.	Same as predicate devices. AIV cables use the same type of construction.
Connector Design: Adapter cable connectors are keyed to fit the appropriate monitors.	Same as predicate devices. Adapter cable connectors are keyed to fit the appropriate monitors.
Installation into System: Installed between monitor and sensor using keyed connectors.	Same as predicate devices. Installed in system between monitor and sensor using keyed connectors.
Target Patient Population: Patients that are well or poorly perfused.	Same as predicate devices.
Patient Use/Reuse: Reusable.	Same as predicate devices.
Sterility: Non-sterile.	Same as predicate devices.
IEC 60601-1 Testing: Passed Safety Testing.	Passed Safety Testing. The company reports conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety.
IEC 60601-1-2 Testing: Passed or equivalent to OEM adapter cable if OEM system not passing with AIV cable.	Passed or shown to be equivalent. When the OEM system did not pass with the AIV cable, the OEM system was tested with the OEM adapter cable to show AIV equivalent to the OEM adapter cable. The company reports conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety.
Overall Performance: Device performs as intended and does not raise new safety/effectiveness issues or alter fundamental technology.	Bench Testing demonstrates that the AIV devices perform as intended. The devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices. This is a conclusion based on the comparison and bench testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for the Test Set: Not explicitly stated as a separate "test set" in the context of an AI/algorithm-driven device. For these types of accessories, the testing primarily involves bench testing and comparison to the physical and electrical characteristics of multiple predicate devices. The number of specific AIV part numbers tested is 13, each corresponding to a different OEM part number for various monitor systems.
Data Provenance: The testing is primarily retrospective, comparing the AIV cables to existing OEM devices and standards. The data is generated from bench testing within the manufacturer's environment to ensure conformity and equivalence. The country of origin of the data is not specified but is inferred to be the manufacturer's location in the USA (Hanover, MD).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (adapter cables) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI diagnostic algorithm would. Instead, engineering and quality assurance personnel perform instrumental measurements and comparisons. The submission mentions "Director of Regulatory Affairs and Quality Assurance" (Gregory Falk), suggesting that qualified personnel within the company are responsible for overseeing the testing and ensuring compliance. Specific numbers or detailed qualifications of technical experts involved in the bench testing are not provided in this summary.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. Adjudication methods (e.g., 2+1) are typically used for interpreting ambiguous cases in diagnostic imaging or similar scenarios where human interpretation is a variable. For adapter cables, compliance is determined by meeting physical, electrical, and performance specifications through direct measurement and comparison, not by consensus among interpreters.

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

Not applicable. This device is an adapter cable, not an AI or diagnostic algorithm, so no MRMC study or AI assistance comparison would be performed.

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

Not applicable. This device is an adapter cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

Predicate Device Specifications: The technical and performance specifications of the legally marketed OEM pulse oximeter adapter cables.
Consensus Standards: International (e.g., IEC 60601-1, IEC 60601-1-2) and national consensus standards for medical electrical equipment safety and electromagnetic compatibility.
Functional Intent: The confirmed ability of the AIV cables to perform the intended function of connecting the sensor to the monitor to allow continuous SpO2 and pulse rate monitoring, without degrading the performance of the overall system.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a hardware accessory, not an AI or machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set or ground truth in the AI/ML sense for this device.

Summary

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K052544

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Supporting Clinical Engineering Worldwide

SEP 2 9 2006

Appendix C Page 1 of 2

510(k) Summarv

Submitter Information:

American IV Products, Inc. 7485 Shipley Avenue Hanover, MD 21076

Contact:

Gregory Falk Director of Regulatory Affairs and Quality Assurance Telephone: 410-787-1300 ext. 129 Fax: 410-787-1337 e-mail: gfalk@aiv-inc.com

Date Prepared:

September 15, 2005

Product Name:

Classification Name: Pulse Oximeter Adapter Cables Common Name: Pulse Oximeter Adapter Cables Proprietary Name: Pulse Oximeter Adapter Cables

Predicate Device:

These AIV devices are equivalent to the following legally marketed devices:

Criticare Model: 518DD - K001020 Corometrics Model: 4033CAX - K934959 Datascope Model: 0012-00-0516-02 - K97006 & K993531 GE Medical Systems Model: E9004GE & 2006644-001 - K012467 & K033304 Nellcor: MC10 - K991823, K993637 & K973147 Nellcor: DEC8 - K971946 Nellcor: SCP10 - K991823, K993637 & K973147 Phillips Model: M1940A - K014159 Phillips Model: M1941A - K993383 Phillips Model: M1943A - K021453 Spacelabs Model: 700-0002-00 - K901209 Spacelabs Model: 700-0030-00 - K972502 Spacelabs Model: 175-0646-00 - K901209 Spacelabs Model: 700-0029-00 - K972502

Description:

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The OEM monitors are used for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.

The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

Intended Use:

These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospital type facilities, intra-hospital transport and home environments.

Comparison to Predicate Device:

	AIV	OEM
Intended Use	The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.	Same
Type of Construction	Flexible, shielded, multi conductor electrical cable.	Same
Connector Design	Adapter cable connectors are keyed to fit the appropriate monitors.	Same
Installation into system	Installed in system between monitor and sensor using keyed connectors.	Same
Target Patient Population	Patients that are well or poorly perfused.	Same
Patient Use/Reuse	Reusable.	Same
Sterility	Non-sterile.	Same
IEC 60601-1 Testing	Passed Safety Testing.	Same
IEC 60601-1-2 Testing	Passed or when OEM system not passing with AIV cable, then OEM system tested with OEM adapter cable to show AIV equivalent to OEM adapter cable.	Same

Performance Data and Conclusions:

. AIV design is equivalent to predicate device design.
Bench Testing demonstrates that the AIV devices perform as intended. .
. The company has declared conformity to consensus standards relating to Electrical/EMC/Mechanical/Safety
. These devices do not raise new issues of safety and effectiveness, nor do they alter the fundamental technology of the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2006

Mr. Gregory Falk Director of Regulatory Affairs and Quality Assurance American I.V. Products. Incorporated 7485 Shipley Avenue Hanover, Maryland 21076

Re: K052544

Trade/Device Name: Pulse Oximeter Adapter Cables Regulation Number: 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: September 5, 2006 Received: September 6, 2006

Dear Mr. Falk:

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. Falk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour 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 Acti: 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 vour 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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Page 1 of

Device Name: Pulse Oximeter Adapter Cables

Indications For Use:

AIV Part #	OEM Part #	OEM Monitor use
CBCSI	518DD	Criticare 504DX, 506DX & Alaris 8100
CBCORO	4033CAX	Corometrics 118 and Fetal Center Monitor
CBDAT	0012-00-0516-02	Datascope Passport, Accutor Plus, Sat 3 & Sat 4
CB10640	E9004GE2006644-001	GE Medical Systems Solar 8000M & 9500M, Solar TramModules T451N & T851N, Dash 2000, 3000 & 4000
CB10587	MC10	Nellcor NPB-290, NPB-295 & N-395
CB10588	DEC8	Nellcor N-20, NPB-40, NPB-75, NPB-190Welch Allyn Protocol PropaqMost BCI Monitors
CB10641	SCP10	Nellcor NPB-290, NPB-295, N395 & N-3000
CBHPHP1	M1940A	Philips M1175A, M1176A, 78352A, 78352C, 78354A,78354C, 7833A, M78833B, M1722A, M1722B, M1723A,M1723B, & M2475B
CB10586	M1941A	Philips M3000A Viridia, M3500B Heartstream XLTDefib/Monitor & M4735A XL Defib/Monitor
CB10590	M1943A	Philips M2601A Viridia, M3000A Viridia, M3500BHeartstream XLT Defib/Monitor & M4735A XLDefib/Monitor
CBSP1	700-0002-00	Spacelabs Monitors with modules: 90351-D/G,90465/66/67, 90489, 90651-A & 90651-08
CBSP2	700-0030-00	Spacelabs Ultraview 1050, 1600, 1700 & all monitorsusing Ultraview Command Module 90496

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Appendix B Page 2 of 2

Page 2 of _ 2__

CBSPNV1	175-0646-00	Spacelabs Monitors with modules: 90351-D/G,90465/66/67, 90489 90651-A & 90651-08
CBSPNV2	700-0029-00	Spacelabs Ultraview 1050, 1600, 1700 & all monitorsusing Ultraview Command Module 90496

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Oles

mesthesiology, General Hosp Is, Junian Dental Devices

ter K052564

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).