The Stryker L3 Hydrolert is intended to monitor irrigant levels primarily during arthroscopic procedures and to alert operating room personnel of a low irrigant fluid level condition. It will offer both increased efficiency in arthroscopic procedures and universal compatibility with both arthroscopic pump and gravity fluid management systems. It is intended for use with saline solution or any other standard irrigant. It is not intended for use as an intravenous infusion monitor. The alarm is designed to be reusable.

Device Description

The MT Alert Infusion Monitor is a passive weighing device that alarms when the infusion bag is near-empty. The alarm point can be set by the user. In addition, MT Alert may also assist in monitoring fluid bolus administration. MT Alert will alarm when a prescribed bolus of fluid has been taken from the infusion bag. MT Alert provides various audio and visual alarms. MT Alert operates from common alkaline batteries and mounts on common poles and rods.

AI/ML Overview

The provided document describes a 510(k) summary for the MT Alert Infusion Monitor (later referenced as Stryker L3 Hydrolert, though the initial summary is for MT Alert). This device is a passive weighing device that alarms when an infusion bag is near-empty.

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 state "acceptance criteria" but rather focuses on demonstrating "substantial equivalence" to a predicate device, the Smith & Nephew Dyonics LeveLert System. The performance is assessed by comparing the features and functions of the MT Alert with the predicate device.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (MT Alert™)
Used for monitoring fluid level of an infusion bag.	Yes	Yes
Automatic alarm when fluid level reaches pre-determined weight with audio and visual alarms.	Yes	Yes
Adjustable near-empty alarm point.	Yes	Yes - Easily programmed by hanging the desired weight.
Accommodates most typical infusion bag sizes.	Yes (up to 3 liter size)	Yes (up to 3 liter size)
Bolus monitoring feature.	No (for LeveLert)	Yes (1 liter mode only) - This is an enhancement over the predicate
Passive device, no fluid control functions.	Yes	Yes
Infusion container hanger.	Yes	Yes
Pole mounting.	Yes	Yes
Power.	External (LeveLert)	2- AA batteries, typical 180 day life - Difference from predicate
Device Class.	Class II	Class II

2. Sample size used for the test set and the data provenance.

The document does not provide any information about a "test set" in the traditional sense of a clinical or performance study with a specific sample size. The validation procedures mentioned are described as indicating the new device is "as safe and effective as the predicate devices," but no details on these procedures or the data provenance are given.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.

This information is not provided in the document. The substantial equivalence argument relies on feature comparison, not independent expert assessment of device performance against a ground truth.

4. Adjudication method for the test set.

This information is not provided. As there is no described "test set" or independent expert review, there is no mention of an adjudication method.

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 monitor for gravity-flow infusions, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its functionality.

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

This information is not provided. Given the nature of the device as a physical monitor, the concept of "algorithm only" performance without human interaction doesn't directly apply in the way it would for, say, an image analysis algorithm. The function of the device is to alarm, and that alarm is inherently for human notification. No standalone performance data is presented beyond the comparison table.

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

The document does not describe the use of a ground truth in the context of a performance study. The ground truth for this submission appears to be the established functionality and performance of the legally marketed predicate device.

8. The sample size for the training set.

This information is not provided. Given that this is a physical monitoring device and not an AI/machine learning product, the concept of a "training set" is not applicable in the usual sense.

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

This information is not provided and not applicable for the reasons stated above.

Summary

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AUG 0 6 2002

1.2 510(k) Summary

Sierra BioSearch, Inc. 395 Mt. Tom Road Bishop, California 93514

510(k) Summary of Safety and Effectiveness

Identification of the Device

Proprietary-Trade Name:	MT Alert Infusion Monitor
Classification Name:	Monitor, Electric for Gravity Flow Infusion Systems
Device Class:	II
Product Code:	FLN
Common/Generic Name:	Gravity Infusion Monitor

Equivalent Predicate Devices

The MT Alert Infusion Monitor is substantially equivalent in design and function to the Smith & Nephew Dyonics LeveLert System.

Indications for Use

MT Alert Infusion Monitor is intended for use in any healthcare setting where gravityflow infusions are utilized.

Description of the Device

Safety and Effectiveness in Comparison to Predicate Devices.

The validation procedures performed on the system indicate that the new device is as safe and effective as the predicate devices.

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Substantial Equivalence Chart

Feature	MT Alert™	LeveLert
Used for monitoring the fluid level of an infusion bag.	Yes	Yes
Automatic alarm when the fluid level has reached a pre-determined weight with audio and visual alarms.	Yes	Yes
Adjustable near-empty alarm point.	Yes- Easily programmed by hanging the desired weight.	Yes.
Accommodates most typical infusion bag sizes.	Yes (up to 3 liter size)	Yes (up to 3 liter size)
Bolus monitoring feature.	Yes (1 liter mode only)	No.
Passive device, no fluid control functions.	Yes	Yes
Infusion Container hangar.	Yes	Yes,
Pole Mounting.	Yes	Yes
Power	2- AA batteries, typical 180 day life	Powered externally
Device Class.	Class II	Class II

Darling Castaneda MB

Richard Citrenbaum, MD, President

(9) (3 / ス / ス / ス / ス /
(Premarket Notification [510(k)] Number)

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle's head and neck, with the head facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 6 2002

Stryker Endoscopy Michael Hilldoerfer 5900 Optical Court San Jose, California 95138

Re: K022248

Trade Name: Stryker L3 Hydroalert Regulation Number: 880.2420 Regulation Name: Electronic Monitor for gravity flow infusion system Regulatory Class: II Product Code: FLN Dated: July 10, 2002 Received: July 12, 2002

Dear Mr. Hilldoerfer:

We have reviewed your Section 510(k) premarket 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 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 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.

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Page 2 -- Mr. Michael Hilldoerfer

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) 594-4659. 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.

R. Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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July 10, 2002

510(k) Number if known:

INDICATION FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

tion (ODE)

Mark N. Milkenon

510(k) Number

Prescription Use

Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

Regulation Number and Section

§ 880.2420 Electronic monitor for gravity flow infusion systems.

(a)
Identification. An electronic monitor for gravity flow infusion systems is a device used to monitor the amount of fluid being infused into a patient. The device consists of an electronic transducer and equipment for signal amplification, conditioning, and display.(b)
Classification. Class II (performance standards).