(461 days)
Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Lady-Comp® USA is a computerized basal body temperature thermometer with the following functions:
- Alarm clock function for measuring temperature at a consistent time.
- Measuring accuracy within +/- 0.05°C (0.09°F).
- Displaying the measured temperature.
- Generating the measurement completion signal.
- Memory Capacity of data for 180 days.
- Transferring the stored data to an external instrument.
I am sorry, but the provided text does not contain detailed information about the acceptance criteria and the study that proves the device meets the acceptance criteria. It primarily focuses on the 510(k) summary for the Lady-Comp® USA device, including its description, intended use, and substantial equivalence to a predicate device.
The document states:
- Measuring accuracy within +/- 0.05°C (0.09°F). This is the only explicit performance characteristic mentioned that could be considered an acceptance criterion for the temperature measurement function. However, no study details are provided to demonstrate how this criterion was met.
There is no information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, or study design for testing.
- Number of experts, qualifications, or adjudication methods for establishing ground truth.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how ground truth for the training set was established.
The core of the document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a detailed performance study report.
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Kosoo94
APPENDIX A
ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴ
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APR 2 0 2006
510 K Summary
Submitter's Name: Lady-Comp USA
Address: 410 East Terrace Heights Jeffersonville, Indianna, USA 47130
Telephone: 502 905 2601 1 866 202 2193
Fax: 812 288 8407
Contact Person: Michael Cartain
Date of Summary: January 6, 2005
Trade Name: Lady-Comp® USA
Common name: Computerized Basal Body Temperature Thermometer
Classification: Device, Fertility Diagnostic, Proceptive Product Code: LHD Unclassified Device
Predicate Device: Petit Sophia, Computerized Basal Body Thermometer, Model No. BT-14E
Lady-Comp® USA is a computerized basal body temperature Device Description: thermometer with the following functions:
-
Alarm clock function for measuring temperature at a consistent time.
-
Measuring accuracy within +/- 0.05°C (0.09°F).
{1}------------------------------------------------
-
- Displaying the measured temperature.
-
- Generating the measurement completion signal.
-
- Memory Capacity of data for 180 days.
-
- Transferring the stored data to an external instrument.
Intended Use: Lady-Comp USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Technological Characteristics: Lady-Comp®USA has the same general design and performance characteristics as the predicate device, Petit Sophia, which is manufactured by Nishitomo Co., Ltd. The main differences include the physical size and shape, display and sensor. Lady-Comp® USA has the same intended use, general design and function, and similar materials and components as the predicate device. Thus, Lady-Comp®USA is considered to be substantially equivalent to the predicate device, Petit Sophia.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 20 2006
Mr. Michael Cartain Branch Manager Lady-Comp USA 410 East Terrace Heights JEFFERSONVILLE IN 47130
Re: K050094
Trade/Device Name: LadyComp® USA Regulation Number: None Regulatory Class: Unclassified Product Code: LHD Dated: March 27, 2006 Received: March 31, 2006
Dear Mr. Cartain:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health". The logo is circular in shape and contains the letters FDA in bold.
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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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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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Indications for Use
510(k) Number (if known): KoSoogy Device Name: _ Lady-Comp® USA Indications for Use:
Lady-Comp® USA is intended for measuring and recording basal body temperature (BBT) as an aid in ovulation prediction to facilitate conception (not to be used for contraception).
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _1 __
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K050094
510(k) Premarket Notification: Lady-Comp® USA January 10, 2005
N/A