(295 days)
K 901512
Not Found
No
The description details a standard clinical thermometer with memory and data transfer capabilities, focusing on temperature measurement accuracy and data storage/display. There is no mention of AI or ML algorithms being used for analysis or prediction. The ovulation prediction is likely based on traditional BBT charting methods.
No
The device is described as "measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception". It assists in diagnosis/prediction, but does not involve treatment or therapy.
Yes
Explanation: The device is used to measure and record basal body temperature (BBT) as an aid in ovulation prediction, which is a process of identifying a medical condition (ovulation) or identifying physiological states. This falls under the definition of a diagnostic device.
No
The device description clearly outlines hardware functions like measuring temperature with specific accuracy, generating a buzz signal, and having memory capacity, indicating it is a physical thermometer, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a clinical thermometer that measures basal body temperature (BBT) directly from the body. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to measure and record BBT as an aid in ovulation prediction. While this information can be used to aid in conception, it is not a diagnostic test performed on a biological sample.
The device is a medical device, specifically a clinical thermometer, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
Product codes (comma separated list FDA assigned to the subject device)
LHD
Device Description
This device is the clinical thermometer with memory the following functions.
(1) Alarm clock function for measuring temperature at constant time.
(2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C) +/-0.1°C(between 34.00°C and 35.00°C, 38.00°C and 40.00°C)
(3) Displaying the measured temperature precisely, generating the measurement completion signal(buzz) and warning of a measuring error by buzzer, in case happened.
(4) Memory capacity of data for 6 menstrual cycles or 210 days.
(5) Displaying the measured temperature value in graph.
(6) Transferring the stored data to an external instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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): 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.
K 901512
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
N/A
0
Nishitomo Co., Ltd. 449-3 Hiruda, Tamaki-cho, Watarai-gun Mie-pref. 519-0423 JAPAN
Sophia
Food and Drug Administration Center for Devices and Radiological Health 510(k) Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 The United States of America
Tel: ++81-596-58 6987 Fax: ++81-596-58 6968 e-mail: sophia@taionkei.com
APR 0 8 2003
510(k) Summary
| Submitter's Name: | Kinji Nishimura
Nishitomo Co., Ltd. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 449-3 Hiruda, Tamaki-cho, Watarai-gun
Mie-prefecture, 519-0423 JAPAN |
| Phone: | ++81-596-58 6987 |
| Fax: | ++81-596-58-6968 |
| E-mail: | sophia@taionkei.com |
| Contact: | Lloyd Duplantis(Official Correspondent) |
| Trade Name: | Petit Sophia, Computerized Basal Body Thermometer
Model No. BT-14E |
| Classification: | Device, Fertility Diagnostic, Proceptive
Product Code: LHD
Registration No.: None
Class: II |
| Predicate Device: | Nishitomo, L Sophia, BT-01
K 901512 |
| Device Description: | This device is the clinical thermometer with memory
the following functions. |
| | (1) Alarm clock function for measuring temperature at constant time. |
| | (2) Measuring accuracy within +/-0.05°C(between 35.00°C and 38.00°C)
+/-0.1°C(between 34.00°C and 35.00°C,
38.00°C and 40.00°C) |
| | (3) Displaying the measured temperature precisely, generating the measurement
completion signal(buzz) and warning of a measuring error by buzzer, in case
happened. |
| | (4) Memory capacity of data for 6 menstrual cycles or 210 days. |
| | (5) Displaying the measured temperature value in graph. |
| | (6) Transferring the stored data to an external instrument. |
1
Nishitomo Co., Ltd. 449-3 Hiruda, Tamaki-cho, Watarai-gun Mie-pref. 519-0423 JAPAN
The Petit Sophia Basal Body Thermometer is intended Intended Use: for measuring, and recording basal body temperature (BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
- The Petit Sophia Basal Body Thermometer has the same Technological Characteristics: general design and performance characteristics as the predicate device "L-Sophia", which is manufactured by the same company Nishitomo Co., Ltd. The main difference is the physical size, shape, weight and temperature display. The Petit Sophia Basal Body Thermometer has the same intended use, general design and incorporates similar materials and components, hence should therefore raise no new questions of safety and effectiveness. This submitter concludes that the Petit Sophia Basal Body Thermometer is therefore substantially equivalent to the predicate device "L-Sophia, BT-01, K 901512".
- Purpose of Submission: The Petit Sophia Basal Body Thermometer, manufactured by Nishitomo Co., Ltd., Japan, is a new device intended to be marketed in the USA.
The Petit Sophia Basal Body Thermometer is similar to another Basal Body Thermometer. approved and marketed in the USA, as the predicate device mentioned below.
Predicate Device: Nishitomo, L-Sophia, BT-01 K 901512(Predicate device) U.S. Contact: Lloyd J. Duplantis, Jr., P.D.(Official Correspondent) Remedies Apothecary, Inc 3696 West Main Street Grav. LA 70359 Tel: 985-872-4547 Fax: 985-580-0213 E-Mail: Ilovdrem@bellsouth.net
Sincerely yours,
11-29-2002
Date(mm/dd/yy)
Kinji Nishimura President Nishitomo Co., Ltd.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nishitomo Co., Ltd. % Mr. Lloyd Duplantis Remedies Apothecary 3696 West Main Street GRAY LA 70359
Re: K021978
APR 0 8 2003
Device Name: Petit Sophia, Electronic Basal Body Thermometer Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LHD Dated: March 12, 2003 Received: March 17, 2003
Dear Mr. Duplantis:
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 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. 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.
3
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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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) you may obtain. 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,
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
4
Page
510(k) Number (if known): K021978
Device Name:_PETIT SOPHIA
Indications For Use:
For measuring, and recording basal body temperature(BBT) as an aid in ovulation prediction to aid in conception (not to be used for contraception).
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Sigmon
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
Prescription Use (Per 21 CFR 801.109) ાર
Over-The-Counter Use
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