TARRY MEDICAL TEMPERATURE PROBES

K071977 · Tarry Medical Products, Inc. · FMZ · May 23, 2008 · General Hospital

Device Facts

• Record ID: K071977
• Device Name: TARRY MEDICAL TEMPERATURE PROBES
• Applicant: Tarry Medical Products, Inc.
• Product Code: FMZ · General Hospital
• Decision Date: May 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.

Device Story

Tarry Medical Temperature Probes (models T-100, T-3000, T-20970, T-20980) function as replacement temperature-sensing components for neonatal incubators and radiant warmers. Probes utilize thermistors to detect skin or air temperature; data is transmitted to the host incubator/warmer system to provide feedback for maintaining pre-selected thermal settings. Used in hospital settings by clinical staff. Probes are compatible with various OEM systems (Drager, Air Shields, Hill-Rom, GE, Ohmeda). Reusable models are designed for use with disposable probe covers. Output allows the incubator/warmer to regulate heat, ensuring stable thermal environments for infants.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility, low-level disinfection, accuracy, comparison, and electrical testing.

Technological Characteristics

Temperature sensing probes utilizing thermistors. Designed as replacement parts for neonatal incubators and radiant warmers. Includes reusable models for use with disposable probe covers. Connectivity is via direct integration with host incubator/warmer systems. No software or active electronic processing within the probe itself.

Indications for Use

Indicated for use as replacement temperature sensing probes for infant radiant warmers and infant incubators to provide skin or air temperature feedback for maintaining pre-selected temperature settings in a hospital setting.

Regulatory Classification

Identification

A neonatal incubator is a device consisting of a rigid boxlike enclosure in which an infant may be kept in a controlled environment for medical care. The device may include an AC-powered heater, a fan to circulate the warmed air, a container for water to add humidity, a control valve through which oxygen may be added, and access ports for nursing care.

Predicate Devices

• Ohmeda / Ohio Care Plus Incubators (K974349)
• Hill-Rom / Air Shields - Isolette Incubators (K001242)
• Hill-Rom / Air Shields - Isolette Incubators (K960980)
• RPI Temperature Probes (K020219)

Submission Summary (Full Text)

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MAY 2 3 2008

Image /page/0/Picture/2 description: The image shows a logo with the word "Tarry" in large, bold, white letters against a textured background. Below "Tarry" is the word "MANUFACTURING" in smaller letters. The logo has a simple, industrial design, suggesting a company involved in manufacturing or related activities. The textured background adds depth and visual interest to the logo.

# 510(k) Summary

## Date Prepared [21 CFR 807.92(a)(1)]: Revised May 22, 2008

#### Submitter's Information [21 CFR 807.92(a)(1)]:

This 510(k) is being submitted by Joseph Azary on behalt Tarry Medical Products.

Contact:

Joseph Azary Senior Regulatory Consultant Orchid Design 80 Shelton Technology Center Shelton, CT 06484 Tel: [phone] Fax: [phone] Email: [e-mail]

Sponsor / Manufacturer:

Tarry Medical Products (dba Tarry Manufacturing) 22 Shelter Rock Lane Danbury, CT 06810 Tel: [phone]

FDA Establishment Registration# 1226711

Trade Name:

The device trade name is Tarry Medical Temperature Probes.

# Device Common, Usual, or Classification Names:

Temperature Probes, Temperature Probes for Neonatal Incubators

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#### Classification:

Class II, Product Code FMZ, Regulation 21 CFR 880.5400

### Predicate Device [21 CFR 807.92(a)(3)]:

The following devices have been identified as predicate devices:

。

Ohmeda Inc - Ohmeda / Ohio Care Plus Incubators - K974349

Hill-Rom / Air Shields - Isolette Incubators - K001242 / K960980

Replacement Parts Industries - RPI Temperature Probes - K020219

#### Description of the Device [21 CFR 807.92(a)(4)]:

The Tarry Medical Temperature Probes are intended to be used as replacement parts as various neonatal incubators including:

!

- Drager / Air Shields / Hill-Rom Isolette Incubators 1
- Drager / Air Shields / Hill-Rom Incubators -
- GE / Ohmeda / Ohio IC and GC Care Plus -
- GE / Ohmeda Panda Baby Warmers -
- GE / Ohmeda Infant Warmer Systems し

This 510(k) includes the following probes:

T-100 (skin temperature probe) T-3000 (skin temperature probe) T-20970 (skin temperature probe) T-20980 (air temperature probe)

The temperature probes are for use with incubators and warmers in a hospital setting. The rne compensate proboble and reusable and reusable models. The probes were designed to meet OEM product specifications.

The temperature probes include thermistors and are used with disposable probe covers.

#### Intended Use [21 CFR 807.92(a)(5)]:

The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.

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#### Technology Characteristics [21 CFR 807.92(a)(6)]:

The device is substantially equivalent to the predicate device based on material, technology, and performance.

#### Performance Data [21 CFR 807.92(b)(1)]:

The subject device has been subjected to biocompatibility, low level disinfection, accuracy, comparison, and electrical testing.

#### Conclusion [21 CFR 807.92(b)(3)]:

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the 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 an abstract image of an eagle.

MAY 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tarry Medical Products, Incorporated C/O Mr. Joseph M. Azary Orchid Design Orthopedic Solutions 80 Shelton Technology Center Shelton, Connecticut 06484

Re: K071977

Trade/Device Name: Tarry Medical Temperature Probes Regulation Number: 21 CFR 880.5400 Regulation Name: Neonatal Incubator Regulatory Class: II Product Code: FMZ, FMZ, FMT Dated: April 30, 2008 Received: May 2, 2008

Dear Mr. Azary:

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 vour 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. Azary

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.

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), please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Ching-Lin, Ph.D.

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):

Device Name:

Tarry Temperature Probes (models T-100, T-3000, T-20970, T-20980)

Indications For Use: The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.

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)

min ha (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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