PETIT SOPHIA

• K Number: K021978
• Device Name: PETIT SOPHIA
• Manufacturer: NISHITOMO CO., INC.
• Date Cleared: 2003-04-08 ( 295 days)
• Product Code: LHD
• Regulation Number: N/A
• Type: Traditional
• Panel: Obstetrics/Gynecology
• Reference & Predicate Devices: N/A
• Predicate For: K102499

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).

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.

AI/ML Overview

The provided text is a 510(k) summary for the "Petit Sophia, Computerized Basal Body Thermometer, Model No. BT-14E". It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through clinical trials. Therefore, much of the requested information regarding acceptance criteria and a study proving performance cannot be directly extracted as it's not present in this type of submission.

However, I can extract the specific performance characteristics mentioned and the basis for substantial equivalence.

Here's the information based on the provided text, with N/A indicating information not found in the document:

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1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Measuring Accuracy	Should be equivalent to the predicate device, L-Sophia, BT-01 (K 901512), which itself must have met established accuracy standards for clinical thermometers.	+/-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)
Memory Capacity	Should be equivalent or improved compared to the predicate device.	6 menstrual cycles or 210 days
Display	Clear display of measured temperature, graphical display of temperature value.	Displaying the measured temperature precisely, generating the measurement completion signal (buzz) and warning of a measuring error by buzzer, in case happened. Displaying the measured temperature value in graph.
Data Transfer	Ability to transfer stored data.	Transferring the stored data to an external instrument.
Alarm Function	Alarm for consistent measurement time.	Alarm clock function for measuring temperature at constant time.

Note: The acceptance criteria for the "Petit Sophia" are primarily based on its substantial equivalence to the predicate device, "L-Sophia, BT-01," described as having "the same general design and performance characteristics." The explicitly stated performance characteristics are a description of the device's features, implicitly suggesting they meet the requirements for a basal body thermometer.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size (Test Set): N/A (The document does not detail a specific test set or clinical study for the Petit Sophia beyond confirming its performance characteristics through comparison to a predicate device.)
• Data Provenance: N/A

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A (No information on ground truth establishment for a test set is provided as the submission relies on substantial equivalence.)

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• N/A (This device is a basal body thermometer, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.)

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• N/A (This device is a physical thermometer with memory and display functions; "standalone" algorithm performance is not applicable in this context.)

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• N/A (The document indicates the device's performance is based on its technological characteristics and intended use being similar to the predicate device, rather than a new ground-truth validation study.)

8. The sample size for the training set

• N/A (No training set is mentioned for this type of device.)

9. How the ground truth for the training set was established

• N/A

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Summary of Device Acceptance and Study Type:

The acceptance of the "Petit Sophia, Computerized Basal Body Thermometer" (K021978) by the FDA is based on a 510(k) Premarket Notification demonstrating substantial equivalence to a legally marketed predicate device, "Nishitomo, L-Sophia, BT-01 (K 901512)".

The document explicitly states: "The Petit Sophia Basal Body Thermometer has the same 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."

Therefore, the "study" proving the device meets acceptance criteria (which are primarily alignment with the predicate device's characteristics and regulatory standards for clinical thermometers) is not a new clinical trial or performance study. Instead, it is a comparison and justification that the new device's specifications (e.g., accuracy, memory, display) are equivalent to those of the predicate device, which was previously cleared by the FDA. The submission asserts that because of this substantial equivalence, the "Petit Sophia" raises no new questions of safety and effectiveness.

Summary

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K021978

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: [e-mail]

APR 0 8 2003

510(k) Summary

Submitter's Name:	Kinji NishimuraNishitomo Co., Ltd.
Address:	449-3 Hiruda, Tamaki-cho, Watarai-gunMie-prefecture, 519-0423 JAPAN
Phone:	++81-596-58 6987
Fax:	++81-596-58-6968
E-mail:	[e-mail]
Contact:	Lloyd Duplantis(Official Correspondent)
Trade Name:	Petit Sophia, Computerized Basal Body ThermometerModel No. BT-14E
Classification:	Device, Fertility Diagnostic, ProceptiveProduct Code: LHDRegistration No.: NoneClass: II
Predicate Device:	Nishitomo, L Sophia, BT-01K 901512
Device Description:	This device is the clinical thermometer with memorythe 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 measurementcompletion signal(buzz) and warning of a measuring error by buzzer, in casehappened.
	(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.

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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: [phone] Fax: [phone] E-Mail: [e-mail]

Sincerely yours,

11-29-2002

Date(mm/dd/yy)

Kinji Nishimura President Nishitomo Co., Ltd.

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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.

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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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[phone]

Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/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

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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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Regulation Number and Section

N/A