MAYBE?MOM MINI OVULATION MICROSCOPE

K013582 · Maybe?Mom · CEP · Jan 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K013582
• Device Name: MAYBE?MOM MINI OVULATION MICROSCOPE
• Applicant: Maybe?Mom
• Product Code: CEP · Clinical Chemistry
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1485
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The MAYBE? MOM® Mini Ovulation Microscope is an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic ovulatory ferning pattern seen in dried saliva. This feming occurs due to increased levels of ovulatory hormones.

Device Story

Hand-held, circular mini-microscope; used by women for OTC self-testing. Input: drop of saliva placed on integrated glass slide. Operation: saliva air-dries (2-6 minutes); user activates LED light source via button; user views dried sample through eyepiece. Output: visual observation of ferning patterns (ovulatory) vs. debris/dots (non-ovulatory). Clinical decision-making: identifies fertile/infertile days to assist in family planning. Benefit: non-invasive, reusable, portable method for tracking ovulation cycles.

Clinical Evidence

Consumer use study (n=93 pre-menopausal women, ages 13-53) showed 97% accuracy in identifying impending ovulation compared to urinary LH kits; salivary ferning identified within 48 hours of LH surge in 92/95 cycles. Readability validated in 28 untrained women; 25/28 cycles showed successful identification of ferning patterns consistent with trained readers.

Technological Characteristics

Hand-held mini-microscope; materials include plastic cylindrical body, glass slide, rubber eye cup, LED light source, and 1.5V battery. Sensing principle: optical visualization of salivary crystallization (ferning). Reusable; requires manual cleaning of slide. No software or connectivity.

Indications for Use

Indicated for pre-menopausal women to identify fertile and infertile days by visualizing dried saliva patterns on a lens to detect ovulation-associated estrogen-induced ferning.

Regulatory Classification

Identification

A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.

Predicate Devices

• Clear Plan® Easy Ovulation Test (K981271)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for a product called "Maybe! mini-ovulation microscope". The logo consists of three large, stylized "m" letters in black. The word "Maybe!" is written in a cursive font across the middle "m". Below the logo, the words "mini-ovulation microscope" are written in a smaller font.

## 510(k) summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K013582

### Submitter Information (21 CFR 807.92(a)(1)

| Submitter: | MAYBE? M.O.M. Inc.<br>318 Sherwood Drive<br>Paramus NJ 07<br>201.866.646.4666<br>Fax: [phone] |
|------------|----------------------------------------------------------------------------------------------------|
|------------|----------------------------------------------------------------------------------------------------|

Contact: Dr Toni Miller LEC Associates 22 Church Street Ramsey NJ 07446 201.615.1212 Phone/fax: [phone]

Summary Date: 5 July 2002

### Name of Device and Classification (21 CFR 807.92(a)(2)

| Name (Trade): | MAYBE? MOM® Mini Ovulation Microscope |
|-----------------|---------------------------------------|
| Name (Usual): | Mini Ovulation Microscope |
| Classification: | 21 CFR 862.1485, Class 1, CEP (75) |

### Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92(a)(3))

The MAYBE? MOM® Mini Ovulation Microscope is substantially equivalent to Clear Plan® Easy Ovulation Test (Unipath Diagnostics Company) cleared under premarket notification K981271.

The MAYBE? MOM® Mini Ovulation Microscope is identical or similar to its predicate in terms of: intended use, risk to user, result interpretation (positive or negative for impending ovulation), test availability (OTC), and clinical performance (ability to identify impending ovulation).

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#### Description of Device (21 CFR 807.92(a)(4)

The MAYBE? MOM® Mini Ovulation Microscope identifies the most fertile day(s) of a woman's menstrual cycle using a direct saliva sample. The fertile day(s) are detected through the observation of distinctive crystallization or ferning patterns seen on a glass slide. The test is self-administered and is completely portable. It requires no reagents nor specific storage conditions and the testing can be performed with relative ease. The results may be interpreted as soon as saliva applied to the slide dries, usually within 2-6 minutes. The MAYBE? MOM® Mini Ovulation Microscope is to be marketed for over-the-counter (OTC) use.

The MAYBE? MOM® Mini Ovulation Microscope consists of:

- a black microscope eyepiece with a microscope slide .
- a rubber eye cup .
- a plastic cylindrical body .
- a battery .
- a light source. .

All of these parts are in place in the unit. The consumer does not do anything to the Mini Ovulation Microscope except to place a drop of saliva on the microscope eyepiece/slide, press the light source to illuminate the salivary feming pattern and focus the microscope to obtain the best view.

The Mini Ovulation Microscope is a hand-held, circular shaped mini microscope containing a miniaturized focusing lens and a miniaturized slide. The slide serves as the platform upon which the saliva is placed and for viewing the dried saliva pattern. The device also includes a miniaturized light source (light emitting diode - LED) that serves as the light source and electronic circuitry. The battery is operated with a replaceable 1.5-volt battery. The Mini Ovulation Microscope is completely reusable, and requires only the cleaning of the mini microscope slide to be reused.

The Mini Ovulation Microscope is designed to be used throughout the menstrual cycle. To perform the test, a small drop of saliva is placed on the slide. After the saliva air-dries (usually in 2-6 minutes), the eve piece is brought to close proximity to the eye for viewing. The black button on the bottom of the Mini Ovulation Microscope is pressed to activate the vellow light that allows viewing of the dried saliva pattern. The non-ovulatory (non-fertile) days are identified by "debris-like" substances, such as dots, circles, or random cells. Ovulatory days are characterized by distinct ferning patterns. Days when some ferning and some random "debris-like" patterns are seen are peri-ovulatory days during which some chance of pregnancy exists.

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# Intended Use (21 CFR 807.92(a)(5))

The MAYBE? MOM® Mini Ovulation Microscope is an over-the-counter device intended to detect the most fertile days of a woman's menstrual cycle by the direct visualization of the characteristic ovulatory ferning pattern seen in dried saliva. This feming occurs due to increased levels of ovulatory hormones.

# Similarities to the Predicate(s) (21 CFR 807.92(a)(6)

A summary table of the similarities and differences between the Mini Ovulation Microscope and the predicate device (Clear Plan® Easy Ovulation Test) follows.

| Parameter | MAYBE? MOM ®<br>Mini Ovulation Microscope | Clear Plan® Easy<br>Ovulation Test |
|-------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Indication For Use | Indication of a woman's fertile<br>and infertile days | Indication of a woman's<br>fertile and infertile days |
| Use | Reusable | Not reusable |
| Risk To Consumer | None: non-invasive<br>Results (positive or negative)<br>do not lead to critical decision<br>or outcomes | None: non-invasive<br>Results (positive or<br>negative) do not lead to<br>critical decision or<br>outcomes |
| Sample Matrix | Saliva | Urine |
| Measured Effect or<br>Analyte | Salivary ferning under the<br>influence of ovulatory<br>hormones | Urinary LH surge under<br>the influence of<br>ovulatory hormones |
| Result Interpretation | Qualitative: positive or<br>negative for impending<br>ovulation | Qualitative: positive or<br>negative for impending<br>ovulation |
| Result Stability | Stable<br>Several months [if not longer]<br>as long as dried saliva is not<br>disrupted | Not stable<br>LH stick must be<br>interpreted within<br>minutes of exposing to<br>urine |
| Test Availability | Over-the-Counter<br>(OTC) | Over-the-Counter<br>(OTC) |

## Comparison of MAYBE? MOM® Mini Ovulation Microscope and Clear Plan® Easy Ovulation Test

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### Brief Discussion of Nonclinical and Clinical Data (21 CFR 807.92(b)(1.2)

In a consumer use study with 93 pre-menopausal women aged 13 to 53, the MAYBE? MOM® Mini Ovulation Microscope was 97% accurate in identifying the imoending ovulation as compared to a urinary LH kit. Salivary ferning was identified within 48 hours pre or post of the first day of the LH surge in 92/95 cycles.

The readability of the MAYBE? MOM® Mini Ovulation Microscope was validated in 28 untrained woman. The consumers were able to identify salivary ferning on at least one of the days when a trained reader identified ferning in 25 of 28 cycles.

## Performance Data - Conclusions (21 CFR 807.02(b)(3)(

The MAYBE? MOM® Mini Ovulation Microscope is substantially equivalent to the Clear Plan® Easy Ovulation Test. Both methods identify the most fertile days of a woman's menstrual cycle and impending ovulation. Clear Plan® Easy Ovulation Test is a urinary LH kit that identifies the mid-cycle LH surge, and the MAYBE? MOM® Mini Ovulation Microscope detects the characteristic ovulatory feming pattern seen in dried saliva. This ferning occurs due to increased levels of ovulatory hormones.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Maybe?Mom c/o Toni Miller Ph.D., DABT, BCFE LEC Associates 22 Church Street Suite 103-244 Ramsey, NJ 07446

JAN 16 2003

Re: K013582/A003

Trade Name: Maybe?MOM® Mini Ovulation Microscope Trace Name: "Hayooriva Name and Number: Luteinizing hormone test system 862.1485 Regulatory Class: Class I Exempt Product Code: CEP Dated: November 12, 2002 Received: November 12, 2002

Dear Ms. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your beceived the device is substantially equivalent (for the indications ferenced above and nave actively marketed predicate devices marketed in interstate for use stated in the encrosare) (o regar) actuation of the Medical Device Amendments, or to connine.cc prior to May 20, 1978, are ecordance with the provisions of the Federal Food, Drug, de vices that have been receasing in quire approval of a premarket approval application (PMA). alle Cosmetic 710-17th, that as nevice, subject to the general controls provisions of the Act. The r ou may, dicrerere, mains 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 It may be subject to suen additions controllations (CFR), Parts 800 to 895. In addition, FDA ean oo found in firther announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal statutes and regulanents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice Trequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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### Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin marketing of substantial equivalence of your device to a legally premarket notheation: "The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you destic specific intoniation assessment wour device, please contact the Office of In of questions on the prometic Device Evaluation and Safety at [phone]. Also, please note the VITO Diaznosto D'Atos Dortos by reference to premarket notification" (21CFR Part 807.97). It guilation cliftined, "Nilsonanang of esponsibilities under the Act may be obtained from the Outcl general information on Jers, 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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Statement of Intended Use

510(k) Number : K 013582

Device Name:

Maybe?MOM® Mini Ovulation Microscope

Indications for Use:

The Maybe MOM® Mini Ovulation Microscope is intended to be used only to indicate when a woman is ovulating by visualizing a woman's dried saliva on a lens. When a woman is ovulating, the increased secretion of estrogen is associated with a fern-like dried salivary pattern.

Sean Cooper M.S., D.VM
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number__K013582

(Please do not write below this point)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) or

Over-the-Counter Use \$\checkmark\$