(80 days)
Not Found
No
The device description focuses on basic temperature sensing technology (thermistors) and a simple feedback loop for temperature control, with no mention of AI or ML algorithms.
No
The device is a temperature probe that monitors patient or air temperature and provides feedback to a temperature controller, which then adjusts the heater output of infant radiant warmers or incubators. It does not directly provide therapy.
No
The device is a temperature probe that monitors and provides feedback for maintaining temperature settings in infant warmers/incubators. It is used to regulate a preselected temperature, not to diagnose a medical condition.
No
The device description explicitly details physical components like thermistor tips, cables, and probes, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The RPI Skin or Air Temperature Probes are designed to measure the temperature of an infant's skin or the air within an incubator/warmer. This is a physical measurement taken externally or within the environment surrounding the patient.
- No sample analysis: The device does not analyze any biological samples taken from the patient. It directly measures temperature.
Therefore, the function and intended use of this device fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.
Product codes
FMT
Device Description
The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin or air temperatue. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe.
The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Infant
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5130 Infant radiant warmer.
(a)
Identification. The infant radiant warmer is a device consisting of an infrared heating element intended to be placed over an infant to maintain the infant's body temperature by means of radiant heat. The device may also contain a temperature monitoring sensor, a heat output control mechanism, and an alarm system (infant temperature, manual mode if present, and failure alarms) to alert operators of a temperature condition over or under the set temperature, manual mode time limits, and device component failure, respectively. The device may be placed over a pediatric hospital bed or it may be built into the bed as a complete unit.(b)
Classification. Class II (Special Controls):(1) The Association for the Advancement of Medical Instrumentation (AAMI) Voluntary Standard for the Infant Radiant Warmer;
(2) A prescription statement in accordance with § 801.109 of this chapter (restricted to use by or upon the order of qualified practitioners as determined by the States); and
(3) Labeling for use only in health care facilities and only by persons with specific training and experience in the use of the device.
0
APR 1 2 2002
Ko206219
510(k) SUMMARY
This 510(k) summary is being submitted in accordance with the requirements of SMDA and21CFR & 807.92
I. NAME OF SUBMITTER
RPI
Replacement Parts Industries, Inc. P.O. Box 5019 Chatsworth, California 913-5019
Phone Number: (818) 882-8611
Contact Person Ira Lapides, President/CEO
Date Prepared:
January 4, 2002
II, DEVICE NAME AND CLASSIFICATION
RPI Skin and Air Temperature Probes Proprietary Name: Skin and Air Temperature Probes Common or Usual Name: Classification: Class II, 21 CFR 880.5130, Infant Radiant Warmers
III. PREDICATE DEVICES
The RPI Temperature Probes are substantially equivalent in design and indications for use to the following devices currently in commercial distribution:
- Accutemp-Probe, Kentec Medical, Inc., 510(k) number K970686 .
- Hill-Rom ISOLETTE Infant Incubator; Hill-Rom Air-Shields, Hatboro, PA 19040; . 510(k) number K001242
- . First Touch Disposables Temperature Probes, First Touch Disposables, Inc., Wilmington, NC 28403; 510(k) number K950422
IV. DESCRIPTION
The RPI Temperature Probes are intended to be used as replacement parts for Air Shields infant radiant warmers and infant incubators. The RPI Temperature Probes are used to monitor the patient's skin temperature or the unit's air temperature when used in conjunction with the infant radiant warmer or infant incubator. The probes are connected to a unit controller to automatically adjust the heater output of the unit to maintain a pre-selected skin
1
or air temperatue. Two of the probes are used in "baby-controlled mode" to monitor the skin temperature of the baby and one of the probes is designed to be used in "air controlled mode", to monitor the air temperature of the incubator or radiant warmer. One probe is a disposable skin temperature probe.
The RPI Skin Temperature Probes have a thermistor tip which is attached to the infant's skin. A cable attaches the probe to the unit controller. The electrical flow resistance changes in response to changes in the skin temperature. This resistance change is converted into a temperature reading. The Skin Temperature Probe is available in three models, including a disposable probe and a reusable probe. The Air Temperature Probe has the same thermistor tip, which is attached to a cable connecting the probe to the controller. The Temperature Probes are provided nonsterile.
V. INTENDED USE
RPI Temperature Probes are designed to be used as replacement temperature sensing probes for use with the temperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide temperature feedback in order to maintain pre-selected temperature settings.
VI. TECHNOLOGICAL CHARACTERISTICS
No new technology, materials, or change in efficacy have been introduced by RPI in the manufacture of the RPI Temperature Probes. The design, form, and materials of the probes are equivalent to their predicate devices in that all are designed to be used to sense temperature information when in the skin or air sensing modes and to feed this information to the incubator of the incubator or radiant warmer. All devices are provided nonsterile to the user. The RPI Temperature Probe and its predicate devices are available as reusable devices or as disposable devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 200
Mr. Ira Lapides President Replacement Parts Industries, Incorporated P.O. Box 5019 Chatsworth, California 91313-5019
Re: K020219
Trade/Device Name: RPI Replacement Temperature Probes Regulation Number: 880.5130 Regulation Name: Infant Radiant Warmer Regulatory Class: II Product Code: FMT Dated: January 16, 2002 Received: January 22, 2002
Dear Mr. Lapides
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 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.
3
Page 2 - Mr. Lapides
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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,
Susan Runner
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Include the following "Indications For Use" page that contains the applicant's name, name of the Include the intended use of the device. The information, data and labeling claims in the entire the 510(k) submission must support and agree with the "indications for use" statement. *For a new submission, do NOT fill in the 510(k) number blank.
INDICATIONS FOR USE
Applicant: Replacement Parts Industries, Inc. (RPI, Inc.)
K020219 510(k) Number (if known): NH
Device Name: RPI Replacement Temperature Probes
Indications For Use:
RPI Skin or Air Temperature Probes are designed to be used as replacement temperature sensing rd i bith of The remperature controller portion of Air Shields infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain preselected temperature settings.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
OR
Over-the-Counter
Susan Rans
(Division Sign-Off) (Division Sign-Onli)
Division of Dental, Infection Control, Division of Deman, Devices of 510(k) Number -