(311 days)
Not Found
No
The device description focuses on basic temperature sensing technology (thermistors) and its use as a replacement part for existing incubators and warmers. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is a temperature probe that provides feedback to maintain pre-selected temperature settings in infant incubators and warmers, which are therapeutic devices themselves. The probe is a diagnostic or monitoring component, not itself treating a condition.
No
The device is a temperature probe used to maintain pre-selected temperature settings in infant incubators and warmers, which is a monitoring/therapeutic function, not a diagnostic one. It provides feedback, but it doesn't interpret physiological signals to identify the presence or absence of a disease or condition.
No
The device description explicitly states that the probes include thermistors, which are hardware components used for temperature sensing. The device is a physical probe, not software.
Based on the provided information, the Tarry Medical Temperature Probes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure skin or air temperature to maintain pre-selected temperature settings in infant radiant warmers and incubators. This is a physiological measurement taken directly from or near the patient, not a test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the use as replacement temperature sensing probes for medical equipment used for patient care.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Tarry Medical Temperature Probes are used for direct physiological monitoring and environmental control for infants.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMZ, FMZ, FMT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin (for skin temperature probes)
Indicated Patient Age Range
Infant (neonatal)
Intended User / Care Setting
Hospital setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device has been subjected to biocompatibility, low level disinfection, accuracy, comparison, and electrical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K974349, K001242, K960980, K020219
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5400 Neonatal incubator.
(a)
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.(b)
Classification. Class II (performance standards).
0
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: (203) 922-0105 Fax: (203) 922-0130 Email: joseph.azary@orchid-orthopedics.com
Sponsor / Manufacturer:
Tarry Medical Products (dba Tarry Manufacturing) 22 Shelter Rock Lane Danbury, CT 06810 Tel: (203) 794-1438
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
1
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.
2
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.
3
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.
4
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
5
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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