TRANSONIC SYRINGE WARMER, MODEL SYR-1000

K022963 · Transonic Systems, Inc. · MQS · Dec 4, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022963
• Device Name: TRANSONIC SYRINGE WARMER, MODEL SYR-1000
• Applicant: Transonic Systems, Inc.
• Product Code: MQS · Gastroenterology, Urology
• Decision Date: Dec 4, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2

Intended Use

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 Story

Device is a syringe warmer (Model SYR-1000) used as an accessory to Transonic HD01-CO Hemodialysis Monitor. Input: 30cc saline syringe. Function: warms saline to approximately body temperature. Output: warmed saline for injection into hemodialysis blood circuit. Used in clinical hemodialysis settings by healthcare providers. Benefit: provides convenient source of body-temperature saline required for cardiac output measurement via the HD01-CO monitor.

Clinical Evidence

Bench testing only. No clinical data provided. Finished products undergo physical testing and visual examination per Quality Control Test Procedure documents to ensure performance parameters conform to design specifications.

Technological Characteristics

Heating device for 30cc syringes. Materials bench-tested for suitability; no patient contact, thus no biocompatibility testing required. Operates as an accessory to the HD01-CO Hemodialysis Monitor.

Indications for Use

Indicated for use as an accessory to Transonic HD01/HD02 hemodialysis systems to warm 30cc saline syringes to body temperature for cardiac output measurements.

Regulatory Classification

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.

Predicate Devices

• HD01-CO Hemodialysis Monitor for Cardiac Output (K980906)
• Vista Dental Syringe Warmer (Class I exempt)

Submission Summary (Full Text)

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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: [phone] |
| Ithaca, NY | Fax: [phone] |

DEC 0 4 2002

| Contact: | Mark S. Alsberge |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Product Name: | Transonic Syringe Warmer |
| Classification name: | Hemodialysis Access Recirculation Monitoring System<br>Gastroenterology and Urology<br>Class II, 78MQS<br>21 CFR §876.5820 |

# SUBSTANTIAL EQUIVALENCE1 TO:

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

# 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.

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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#### 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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.

(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)