The Transonic Syringe Warmer (Model SYR1000) is indicated for use with the Transonic HD01 (HD01PMS and HD02) systems to make Cardiac output measurements. The Transonic Syringe Warmer (Model SYR1000) is an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906) which are currently marketed as the HD01046 and HD02 systems. The HD01-CO Hemodialysis Monitor for Cardiac Output (HD01P05 and HD02 systems) requires the user to make a 30cc injection of approximately body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer provides the user a convenient source of the 30cc injection of approximately body temperature saline for this injection.

Device Description

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, Transonic Systems Inc. intends to introduce into interstate commerce the Transonic Syringe Warmer as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). The HD01-CO Hemodialysis Monitor for Cardiac Output requires the user to make a 30cc injection of ~ body temperature saline into the hemodialysis blood circuit for the CO measurement. The syringe warmer will provide the user a convenient source of the 30cc injection of ~ body temperature saline for this injection.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Transonic Syringe Warmer, an accessory device. The information primarily focuses on establishing substantial equivalence to a predicate device and does not contain detailed acceptance criteria, specific study designs, or performance metrics in a quantitative manner typical for AI/ML device submissions.

Based on the provided text, I can infer the general nature of the "acceptance criteria" and "study" as implied by the FDA's "Safety and Effectiveness" section, but there are no specific numerical thresholds or detailed study results. The submission relies on demonstrating the device is similar to a predicate device and meets general quality control requirements.

Here's an analysis based on the provided text, attempting to address your points as much as possible, while noting where information is absent for this type of submission:

Acceptance Criteria and Study for the Transonic Syringe Warmer

The Transonic Syringe Warmer is an accessory device intended to warm a 30cc syringe of saline to approximately body temperature for injection into a hemodialysis blood circuit. The acceptance criteria and supporting "study" described are focused on demonstrating the device's safety and effectiveness and its substantial equivalence to a predicate device, rather than a quantifiable performance study against specific metrics for AI/ML devices.

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

Based on the document, the acceptance criteria are implicitly tied to "release specifications" and "product design specifications." The "reported device performance" is essentially that the device functions as intended to warm saline.

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Designed for intended use	Suitable for warming a 30cc syringe of saline to ~body temperature for CO measurement.
Made of suitable materials	Bench tested materials suitable for intended use.
Meets required release specifications	All finished products are tested and meet all required release specifications before distribution.
Conforms to product design specifications	Established testing procedures ensure performance parameters conform to specifications.
No new issues of safety or effectiveness	The use difference (warming saline vs. dental anesthetic) does not raise any new safety or effectiveness issues.

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

The document does not specify a "test set" in the context of a typical AI/ML study with data points. Instead, it refers to "all finished products" being tested.

Sample Size: "All finished products" are tested. This implies a 100% inspection or testing of manufactured units.
Data Provenance: Not applicable in the context of clinical data. The tests are bench tests performed by the manufacturer, Transonic Systems Inc. (located in Ithaca, NY, USA).
Retrospective/Prospective: Not applicable. These are manufacturing quality control tests, not clinical studies.

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

This information is not applicable to the type of device and submission described. There is no mention of experts establishing ground truth for a test set, as this is a hardware device undergoing manufacturing quality control rather than a diagnostic AI/ML algorithm.

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

Not applicable. There is no "test set" requiring adjudication in the context of clinical or diagnostic performance. The testing described is internal quality control.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices, not for a syringe warmer. There is no AI component mentioned in this device.

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

No, a standalone algorithm-only performance study was not done. This device is a hardware accessory and does not contain an AI algorithm.

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

The "ground truth" for this device's performance is based on its adherence to manufacturing specifications and its ability to perform its stated function (warming saline to ~body temperature). This would be validated through engineering measurements and quality control checks, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

Not applicable. This device does not use machine learning or have a "training set."

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

Not applicable. This device does not use machine learning or have a "training set."

Summary of the "Study" Described:

The "study" demonstrating the Transonic Syringe Warmer meets its acceptance criteria is best described as a comprehensive quality control and manufacturing testing process rather than a clinical trial or AI performance study.

Process: "All finished products are tested and must meet all required release specifications before distribution."
Testing Types: "physical testing, visual examination (in process and finished product)."
Methodology: "The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications."
Documentation: "The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP's."

The submission primarily relies on demonstrating substantial equivalence to a predicate device (Vista Dental Anesthetic Syringe Warmer) and asserting that the modified intended use (warming saline for hemodialysis monitoring) "does not raise any new issues of safety or effectiveness." This approach underscores that the primary evidence for this particular 510(k) submission is related to manufacturing quality and equivalence, not advanced performance metrics or clinical study data.

Summary

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510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90

September 5, 2002

Transonic Systems Inc.
34 Dutch Mill Rd	Telephone: (607) 257-5300
Ithaca, NY	Fax: (607) 257-7256

DEC 0 4 2002

Contact:	Mark S. Alsberge
Product Name:	Transonic Syringe Warmer
Classification name:	Hemodialysis Access Recirculation Monitoring SystemGastroenterology and UrologyClass II, 78MQS21 CFR §876.5820

SUBSTANTIAL EQUIVALENCE1 TO:

510 (k) Number	Name	Applicant
K980906	HD01-CO Hemodialysis Monitorfor Cardiac Output	Transonic Systems Inc.
Class I exempt	Vista Dental Syringe Warmer	Inter-Med Inc. / Vista Dental Products
872.6100 Anesthetic warmer

Device Description:

1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and diminish any patent claims related to this product or the technology used to manufacture the product.

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022963 AGE 2 OF 2

Material:

The Transonic Syringe Warmer is made of materials which have been bench tested and demonstrated themselves to be suitable for the intended use of this product. The materials have no patient contact; therefore, no biocompatibility testing was completed.

Substantial equivalence:

The Transonic Syringe Warmer is similar in materials and form to the Vista Dental Anesthetic Syringe Warmer currently marketed by Inter-Med Inc. / Vista Dental Products (Class I Exempt, 872.6100 Anestheic warmer). The Transonic Syringe Warmer introduces a slight modification to the intended use. The Transonic Syringe Warmer will be used as an accessory to our HD01-CO Hemodialysis Monitor for Cardiac Output (K980906). They will be used to warm a 30cc syringe of saline to ~ body temperature for injection into the hemodialysis blood circuit rather than to warm dental anesthetic for injection into the patient. This use difference does not raise any new issues of safety or effectiveness regarding the Transonic Syringe Warmer.

Safety and Effectiveness:

All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release includes, but are not limited to; physical testing, visual examination (in process and finished product

The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures that ensure the products performance parameters conform to the product design specifications.

The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control cGMP"s.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in a simple, sans-serif font. The text is black and appears to be on a white background. The words are arranged on a single line, with "Public" and "Health" being the most prominent words.

Food and Drug Administrat 200 Corporate Boulevard Rockville MD 20850

Mr. Mark S. Alsberge VP Medical and Regulatory Affairs Transonic Systems, Inc. 34 Dutch Mill Road ITHACA NY 14850-9787

Re: K022963 Trade/Device Name: Transonic Syringe Warmer Model SYR-1000 Regulation Number: 21 CFR 8876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 MOS Dated: September 5, 2002 Received: September 6, 2002
Dear Mr. Alsberge:

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. Iisting 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 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 mav 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.

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or progress.

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Page 2

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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): - Transonic Syringe Warmer_(Model SYR1000) Device Name: Indications for Use:

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use √

Emid A. Syeam

o of Reproductive, Abdominal, adiological Devices, 51()(k) Number _

(Optional Format 3-10-98)

(Posted July 1, 1998)

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.