ZZOMA POSITIONAL SLEEPER MODEL 001

K100160 · Sleep Specialists, LLC · MYB · May 11, 2010 · Dental

Device Facts

• Record ID: K100160
• Device Name: ZZOMA POSITIONAL SLEEPER MODEL 001
• Applicant: Sleep Specialists, LLC
• Product Code: MYB · Dental
• Decision Date: May 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring. The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use. Caution: Federal law restricts the device to sale by or on the order of a physician or dentist.

Device Story

ZZOMA Positional Sleeper is a wearable, non-electronic, mechanical device designed to prevent supine sleeping. It consists of a semi-rigid synthetic foam wedge contained in a backpack-style harness with an adjustable Velcro elastic belt. The device is worn on the back; the wedge-shaped design physically keeps the user in a lateral (side) position during sleep. It is used in a clinical or home setting under the guidance of professional healthcare personnel. By preventing the supine position, the device reduces airway obstruction in patients with positional OSA, thereby alleviating snoring and improving sleep quality. It serves as an alternative to CPAP therapy for positional OSA patients.

Clinical Evidence

Clinical study compared ZZOMA Positional Sleeper to CPAP therapy in patients with positional OSA. Study findings: 1) Positional therapy is equivalent to CPAP in normalizing the apnea-hypopnea index (AHI) in positional OSA patients; 2) Decreased AHI by >30%; 3) Similar to CPAP regarding effects on sleep quality and nocturnal oxygenation; 4) Effective at maintaining patients in the non-supine position throughout the night.

Technological Characteristics

Mechanical positional therapy device. Materials: semi-rigid synthetic foam core, nylon outer cover, cotton-covered body contact surface with PVC dots for stability. Dimensions: 12 x 5.5 x 4 inches. Form factor: backpack-style harness with adjustable Velcro elastic belt. Non-electronic; no energy source. No software or connectivity.

Indications for Use

Indicated for patients with mild to moderate, predominantly positional obstructive sleep apnea (OSA) and for the reduction or alleviation of snoring. Intended for professional use by trained healthcare personnel.

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• Sona Pillow (K040161)
• Sniff Position Pillows/Popitz Pillows (K023010)

Submission Summary (Full Text)

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K100/60

# Exhibit 1 510(k) Summary

- 1 510(k) Summary
MAY 1 1 2010

Date of Summary Preparation: May 7, 2010

| 1.2 | Submitter: | Joseph Crocetti, DO<br>Sleep Specialists, LLC<br>P.O. Box 610<br>Abington, PA 19001<br>Phone: [phone]<br>E-mail: [e-mail] |
|-----|------------|---------------------------------------------------------------------------------------------------------------------------------------------|
|-----|------------|---------------------------------------------------------------------------------------------------------------------------------------------|

1.3 Trade Name: ZZOMA Positional Sleeper

Classification Name, Product Code, Class, Classification Reference: 1.4

| Classification Name | Common Name | Product Code | Class | 21CFR § |
|---------------------|-------------|--------------|-------|----------|
| | ZZOMA | MYB | II | 872.5570 |
| | Positional | | | |
| | Sleeper | | | |

1.5 Standards/Special Controls:

None

- 1.6 Indications for Use:
The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate obstructive sleep apnea (OSA) and to reduce or alleviate snoring.

The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

#### 1.7 Device Description:

The ZZOMA Positional Sleeper is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam (Figures 1 and 2). It is contained in a backpack type material with an associated Velcro® elastic belt. The device is worn on the back, with the elastic belts brought around each side of the subject and secured anteriorly with the adjustable straps. The particular size and wedge-shaped design on both sides of this device keeps the subject comfortably positioned on their side, and prevents him/her from assuming the supine position. The ZZOMA has a firm inner core made of foam and the outer part of the device is covered in nylon, and the part that touches the subject's body is cotton covered with a coating of PVC dots that help keep the ZZOMA in place while you sleep.

Substantially Equivalent Commercially Available Devices: · 1.8

The ZZOMA Positional Sleeper device is substantially equivalent to the predicate device described herein with respect to indications for use:

· Sleep Devices, Inc. Sona Pillow - K040161

Aeolus International Corporation, Sniff Position Pillows/Popitz Pillows - K023010

The predicate devices (Sona Pillow and Sniff Position Biollows/Popitz Pillows) are commercially available and marketed Class II devices.

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#### 1.9 Substantial Equivalence Comparison:

·

l

| ZZOMA Positional Sleeper | Predicate Sleep Devices,<br>Inc, Sona Pillow –<br>K040161 | Equivalency |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| The ZZOMA Positional Sleeper is<br>indicated for use and intended for<br>non-professional, over-the-counter<br>use and for professional use for the<br>treatment of mild to moderate<br>obstructive sleep apnea (OSA) and to<br>reduce or alleviate snoring. | May stop or decrease snoring<br>May be used to treat mild<br>obstructive sleep apnea<br>May improve the quality of sleep | Same - Treats<br>mild obstructive<br>sleep apnea<br>Same –<br>regarding<br>effects on<br>snoring<br>Different – does |
| | | not disrupt<br>sleep quality<br>Different – |
| | | treats both mild<br>and moderate<br>sleep apnea |

# INDICATIONS FOR USE

# METHODOLOGY

| ZZOMA Positional Sleeper | Predicate | Equivalency |
|--------------------------|--------------------------------|-------------------------------------------------------------------------------|
| Positions on the back | Positions on the head and neck | Same - both<br>devices prevent<br>subjects from<br>sleeping on<br>their backs |
| | | Different -<br>Pillow positions<br>head, Zzoma<br>positions back |

## PERFORMANCE

| ltem | ZZOMA Positional<br>Sleeper | Predicate | Equivalency |
|-------------|-----------------------------------------|-----------------------------------------|-------------|
| Storage | Room temperature | Room temperature | Same |
| Positioning | Keep subject off back while<br>sleeping | Keep subject off back<br>while sleeping | Same |

A clinical study was conducted to examine the non-inferiority of the Zzoma Positional Sleeper and CPAP therapy on the apnea-hypopnea index after one night of therapy in patients with positional obstructive sleep apnea.

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i A secondary objective was to evaluate the ability of the Zzoma Positional Sleeper to maintain the patient in the lateral position was to evaluate the ability of in objective is to evaluate the initial effects of the in the lateral position during sloop. Thistier observer, and compare it to initial effects seen with CPAP therapy.

There were 4 major findings in this study: 1) in patients with positional OSA, positional therapy is There were 4 major in this study. 7/11 pations with in addition to decreasing the AHI by > equivalent to CPAP therapy at nomalizing the Arr o - regards to effects on sleep quality and nocturnal 30%, 2) positional meraly is siniliar to Or X. " trerapy in 70garane AHI in patients with positional oxygenation, of there is milliffer the at maintaining patients in the non-supine position throughout the night.

# 1.10 Indications and Contraindications:

Relative indications and contraindications for the ZZOMA Positional Sleeper and positional commercially relative indications and contrained uses (treating moderate positional sleep apena) are similar.

1.11 Conclusion:

In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Sleep Specialists, LLC concludes that the new information provided in the pro manect nosffective and substantially equivalent to the predicate devices as described herein.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a stylized symbol. The symbol is a representation of a human figure embracing or protecting another person, conveying a sense of care and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

# MAY 1 1 2010

Sleep Specialists, LLC c/o Mr. Howard Mann 1 Congressional Drive, Apt C Greenville, Delaware 19807

Re: K100160

Trade/Device Name: ZZOMA Positional Sleeper Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: MYB Dated: March 29, 2010 Received: April 6, 2010

Dear Mr. Mann:

-

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. Howard Mann

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Rua. Hien, M.D.

Malvina B. Eydelman, M Director Division of Ophthalmic, Neuroloical, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### EXHIBIT B Indications for Use Statement

Indications for Use .

### 510(k) K100160:

Device Name: ZZOMA Positional Sleeper

Indications for Use:

The ZZOMA Positional Sleeper is indicated for use and intended for professional use for the treatment of mild to moderate, predominantly positional obstructive sleep apnea (OSA) and to reduce or alleviate snoring.

The ZZOMA Positional Sleeper is intended for use by professional healthcare personnel trained in its use.

Caution: Federal law restricts the device to sale by or on the order of a physician or dentist.

AND/OR Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anatolet

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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k100160