The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate.

The intended patient population for the UniProbe includes adult, pediatric and neonatal patients. Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor.

The UniProbe may be used in any hospital or hospital-type environment where the specified compatible monitors may be used. The UniProbe is contraindicated for use during MRI scanning. The UniProbe is NOT intended for use in the home care environment. The UniProbe is a prescription device and is to be used by qualified health care professionals only.

Device Description

That is, the UniProbe Adapter Cable allows the user to substitute Nellcor brand sensors for Ohmeda brand sensors when measuring SpO2 with the specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximetry monitors.

The UniProbe has been designed and tested to be compatible with the following monitors:

Ohmeda Models: 3700, 3700e, 3740, 3760, 3800

Marquette Tram® Models (Ohmeda compatible): 200, 200A, 200SL, 400A, 400SL, 600, 600A, 600SL, 800A, 800SL

The major components of the UniProbe are a molded plastic housing that contains a pair of printed circuit boards sandwiched together. The circuit consists primarily of analog components with no software driven circuitry. The UniProbe's body is approximately 6 inches long with a 10 foot sensor cable attached at one end and a power cable and monitor cable attached at the other end.

The sensor cable is approximately ten feet long and terminates in a 9-pin sensor connector that accepts a Nellcor brand oximetry sensor.

The power cable and monitor cable emerge together from the opposite end of the housing and are approximately eighteen inches long.

The power cable terminates in a coaxial barrel connector (power plug) that connects to one of three possible power connectors, depending on the model of monitor it is used with.

The monitor cable has a Hypertronics connector (monitor connector) that plugs into the sensor (Patient or SpO2) port of the oximeter.

The UniProbe is supplied in 3 different configurations depending on the Ohmeda or Ohmeda-compatible Marquette Tram monitor used. Power must be supplied to the UniProbe using one of three different power connectors as listed in the following table:

Compatible Monitor	UniProbe Configuration Model Number	Power Connector
Marquette Tram Monitors	UP12A	Front Panel Power
Ohmeda 3740, 3760	UP12B	Rear Panel Power
Ohmeda 3700, 3700e, 3800	UP12C	AC Wall Power

The Front Panel Power Connector (part of configuration UP12A) is designed to plug into the "DISPL" socket on the front panel of the Marquette Tram. The UniProbe's power plug plugs into a mating connector mounted within the Front Panel Power Connector.

The Rear Panel Power Connector (part of configuration UP12B) connects between the oximeter's own power cord and rear panel power inlet. The UniProbe's power plug plugs into a mating connector mounted within the Rear Panel Power Connector.

The AC Wall Power Connector (part of configuration UP12C) consists of a switching power supply that connects to the power plug of the UniProbe.

A UniProbe Adapter Cable is shipped with one power connector, Velcro strips and a DFU in a carton.

AI/ML Overview

The provided document describes the Nellcor Puritan Bennett UniProbe Adapter Cable, which allows Nellcor brand sensors to be used with specified Ohmeda and Ohmeda-compatible Marquette Tram pulse oximeters. The primary purpose of the device is to provide noninvasive measurement of arterial oxygen saturation and pulse rate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of numerical acceptance criteria (e.g., specific SpO2 accuracy ranges with corresponding pass/fail thresholds) or a side-by-side comparison with reported performance values. Instead, it states that the device's accuracy and performance were demonstrated to be equivalent to existing predicate devices.

The key statement regarding performance is:
"Test results confirmed that the oxygen saturation accuracy performance of the UniProbe/D25 combination was equivalent to the OxyTip A/P across the recommended device line." (Page 4, Section 6)

And, "The results of the Co-oximeter Correlation Study clearly demonstrate that the UniProbe, when used with the specified Ohmeda or Ohmeda compatible Marquette monitors, meets the stated accuracy specifications." (Page 5)

While specific numerical acceptance criteria are not provided, the "stated accuracy specifications" likely refer to the established accuracy specifications of the predicate devices. The study aimed to show equivalence or compliance with these existing specifications rather than defining new ones for the adapter cable itself.

Summary of "Acceptance Criteria" (Inferred from Equivalence Claim) and Reported Performance:

Acceptance Criteria (Inferred)	Reported Device Performance Statement
Oxygen saturation accuracy performance must be equivalent to the Ohmeda 3740/OxyTip A/P combination.	"Test results confirmed that the oxygen saturation accuracy performance of the UniProbe/D25 combination was equivalent to the OxyTip A/P across the recommended device line."
The device (UniProbe with specified monitors) must meet stated accuracy specifications.	"The results of the Co-oximeter Correlation Study clearly demonstrate that the UniProbe, when used with the specified Ohmeda or Ohmeda compatible Marquette monitors, meets the stated accuracy specifications." This was specifically tested in a "blood study over the specified saturation range of 70% - 100%," suggesting the "stated accuracy specifications" refer to performance within this range.
Compliance with environmental and EMC requirements.	"Environmental and EMC testing has been conducted as recommended by the applicable sections of the Reviewer's Guidance for Premarket Notification Submissions. November 1993. Testing results demonstrated that all applicable requirements have been met."

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

Sample Size: The document does not explicitly state the sample size (number of subjects or data points) for the "in vivo clinical testing" or the "Co-oximeter Correlation Study." It mentions "blood study over the specified saturation range of 70% - 100%," which implies a certain number of measurements were taken to cover this range.
Data Provenance: The document does not specify the country of origin of the data. It indicates the studies were "in vitro and in vivo clinical testing," which implies prospective data collection, especially for the "Co-oximeter Correlation Study."

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 section is not applicable to the evaluation of this device. The ground truth for oxygen saturation measurements in the Co-oximeter Correlation Study would typically be established by a reference co-oximeter (a laboratory instrument that measures oxygen saturation directly from blood samples), not by human expert consensus or clinical expert review in the way it would be for image-based diagnostic devices. The document refers to it as a "blood study," confirming this method. Therefore, no human experts were involved in establishing the ground truth directly for the test set in the conventional sense of expert review for diagnostic accuracy.

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

This is not applicable. The nature of the device (adapter cable for a pulse oximeter) and the type of evaluation (comparison against a reference co-oximeter for oxygen saturation accuracy) do not involve human adjudication of results in the way a diagnostic imaging study would.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was conducted. This type of study is typically relevant for interpretative diagnostic devices (e.g., AI for radiology images) where human readers are involved in interpreting results, and the AI's role is to assist or improve their performance. The UniProbe Adapter Cable is a measurement device, not an interpretive one, and its evaluation focuses on measurement accuracy rather than human interpretation performance.

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

Yes, a standalone performance evaluation was done. The "Co-oximeter Correlation Study" and the comparison against the Ohmeda 3740/OxyTip A/P combination represent standalone performance evaluations of the device combination (monitor/UniProbe/Nellcor sensor). The performance of the device system itself was assessed against a presumed gold standard (co-oximeter) for its accuracy in measuring SpO2 and pulse rate. The human user is operating the device but not interpreting its primary output in a way that requires human-in-the-loop performance assessment where the human is the variable.

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

The ground truth for the "Co-oximeter Correlation Study" was established through blood samples analyzed by a co-oximeter. This is the standard method for determining the true arterial oxygen saturation (SaO2) in such studies, against which the pulse oximeter's estimated SpO2 is compared.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI. The UniProbe is described as having "analog components with no software driven circuitry" (Page 2), indicating it is not a software-based device that would require machine learning training. Its design and testing were likely based on engineering principles and established physiological models for pulse oximetry, rather than data-driven statistical training.

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

As there is no mention of a "training set" or machine learning components for this device, this question is not applicable.

Summary

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7 1498 liec

Nellcor Puritan Bennett UniProbe Adapter Cable 510(k) Summary December 3, 1998 Page 1 of 5

1. COMPANY INFORMATION

Establishment:

Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588

Official Correspondent:

Sheryll A. Mathews Sr. Requlatory Affairs Specialist

DEVICE NAME . 2.

Proprietary:

Common/Usual:

Classification:

UniProbe Adapter Cable

Adapter Cable

Oximeter, 74DQA

EQUIVALENT DEVICE 3.

The UniProbe/Nellcor brand sensor combination used in conjunction with the specified Ohmeda or Ohmeda-compatible Marquette Tram monitors is substantially equivalent to the specified monitors used in conjunction with an Ohmeda sensor. The 510(k) numbers for the specified monitors/Ohmeda sensor combination are listed below;

Product	510(k) Number	Date Cleared
Ohmeda Biox 3700/3700ePulse Oximeter	K850494	3/28/85
Ohmeda Biox 3740 PulseOximeter	K872772	10/7/87
Ohmeda Biox 3760 PulseOximeter	K874104	12/3/87
Ohmeda 3800 PulseOximeter	K962127	10/10/96
Marquette Tram Modules	K921669	5/7/93

Nellcor Puritan Bennett Inc. 510(k) Premarket Notification UniProbe Adapter Cable #K982728 Additional Information - Confidential

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P. 4

Nellcor Puritan Bennett UniProbe Adapter Cable 510(k) Summary December 3, 1998 Page 2 of 5

DEVICE DESCRIPTION 4.

The UniProbe has been designed and tested to be compatible with the following monitors:

Ohmeda Models: 3700, 3700e, 3740, 3760, 3800

Marquette Tram® Models (Ohmeda compatible): 200, 200A, 200SL, 400A, 400SL, 600, 600A, 600SL, 800A, 800SL

The sensor cable is approximately ten feet long and terminates in a 9-pin sensor connector that accepts a Nellcor brand oximetry sensor.

The power cable and monitor cable emerge together from the opposite end of the housing and are approximately eighteen inches long.

The power cable terminates in a coaxial barrel connector (power plug) that connects to one of three possible power connectors, depending on the model of monitor it is used with.

The monitor cable has a Hypertronics connector (monitor connector) that plugs into the sensor (Patient or SpO2) port of the oximeter.

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Nellcor Puritan Bennett UniProbe Adapter Cable 510(k) Summary December 3, 1998 Page 3 of 5

The UniProbe is supplied in 3 different configurations depending on the Ohmeda or Ohmeda-compatible Marquette Tram monitor used. Power must be supplied to the UniProbe using one of three different power connectors as listed in the following table:

Compatible Monitor	UniProbeConfigurationModel Number	Power Connector
Marquette Tram Monitors	UP12A	Front Panel Power
Ohmeda 3740, 3760	UP12B	Rear Panel Power
Ohmeda 3700, 3700e, 3800	UP12C	AC Wall Power

The AC Wall Power Connector (part of configuration UP12C) consists of a switching power supply that connects to the power plug of the UniProbe.

A UniProbe Adapter Cable is shipped with one power connector, Velcro strips and a DFU in a carton.

5. INTENDED USE

Nellcor Puritan Bennett Inc. 510(k) Premarket Notification UniProbe Adapter Cable #K982728 Additional Information - Confidential

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Nellcor Puritan Bennett UniProbe Adapter Cable 510(k) Summarv December 3, 1998 Page 4 of 5

The intended patient population for the UniProbe includes adult, pediatric and neonatal patients. Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor.

TECHNOLOGICAL CHARACTERISTICS હ.

The new device (a UniProbe/Nellcor brand sensor used with an Ohmeda or Ohmeda-compatible Marquette Tram monitor) and the predicate devices (Ohmeda 3700, 3700e, 3740, 3760, 3800 pulse oximeters and Ohmeda-compatible Marquette Tram monitors all used with an OxyTip sensor), all measure oxygen saturation and pulse rate using equivalent technology. The technological characteristics of the new device and the currently marketed predicate devices are equivalent.

Comparative Performance Evaluations:

The safety and effectiveness of the UniProbe Adapter Cable has been demonstrated by design and testing. Environmental and EMC testing has been conducted as recommended by the applicable sections of the Reviewer's Guidance for Premarket Notification Submissions. November 1993. Testing results demonstrated that all applicable requirements have been met.

The accuracy and performance of the Ohmeda or Ohmeda-compatible Marquette Tram monitor/UniProbe/Nelicor brand sensor combinations have been demonstrated through in vitro and in vivo clinical testing. The Ohmeda 3740/OxyTip A/P combination was compared to the Ohmeda 3700, 3740, 3760, 3800, Tram 600/UniProbe/D25 combination, Test results confirmed that the oxygen saturation accuracy performance of the UniProbe/D25 combination was equivalent to the OxyTip A/P across the recommended device line.

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Nellcor Puritan Bennett UniProbe Adapter Cable 510(k) Summary December 3, 1998 Page 5 of 5

To further demonstrate that the UniProbe met the stated accuracy specifications, a Co-oximeter Correlation Study (blood study over the specified saturation range of 70% - 100%) was performed using the Marquette TRAM with UP12A, Ohmeda 3740 with UP12B and Ohmeda 3740 with UP12C. These systems are considered representative of all specified Ohmeda and Ohmeda compatible Marquette monitors when used with the appropriate UniProbe Adapter Cable.

The results of the Co-oximeter Correlation Study clearly demonstrate that the UniProbe, when used with the specified Ohmeda or Ohmeda compatible Marquette monitors, meets the stated accuracy specifications.

Nellcor Puritan Bennett Inc. 510(k) Premarket Notification UniProbe Adapter Cable #K982728 Additional Information - Confidential

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 7 1998

Ms. Sherry Mathews Nellcor Puritan Bennett Inc. 4280 Hacienda Drive Pleasanton, CA 94588-2719

Re: K982728 UniProbe Adapter Cable Models UP12A, UP12B and UP12C Requlatory Class: II (two) Product Code: 74 DQA Dated: Undated Received: November 20, 1998

Dear Ms. Mathews:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sherry Mathews

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known):

To be assigned K962728

Nellcor Puritan Bennett UniProbe Adapter Cable Device Name:

Indications For Use:

The UniProbe Adapter Cable allows specified Nellcor brand reusable and patient-dedicated oxygen sensors to be used with specified Ohmeda-compatible Marquette Tram pulse oximetry monitors, to provide noninvasive measurement of oxygen saturation and pulse rate.

The intended patient population for the UniProbe Adapter Cable includes adult, pediatric and neonatal patients. Use with any particular patient requires selection of an appropriate Nellcor brand oxygen sensor.

The UniProbe Adapter Cable may be used in any hospital-type environment where the specified compatible monitors may be used. The UniProbe is contraindicated for use during MRJ scanning. The UniProbe Adapter Cable is NOT intended for use in the home care environment. The UniProbe Adapter Cable is a prescription device and is to be used by qualified health care professionals only,

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Mark Kramer
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Nellcor Puritan Bennett Inc. 510(k) Premarket Notification UniProbe Adapter Cable #K982728 Additional Information - Confidential

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).