RESPIRONICS CUSTOM I ORAL APPLIANCE

K033822 · Respironics, Inc. · LRK · Feb 6, 2004 · Dental

Device Facts

• Record ID: K033822
• Device Name: RESPIRONICS CUSTOM I ORAL APPLIANCE
• Applicant: Respironics, Inc.
• Product Code: LRK · Dental
• Decision Date: Feb 6, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.

Device Story

The Respironics Custom I Oral Appliance is a removable mandibular repositioning dental device; used to treat snoring and obstructive sleep apnea. The device is fitted by a trained dentist; the fitting process involves boiling the device and having the patient bite down to create a custom impression. The device functions by repositioning the mandible; it is intended for prescription use. It serves as an aid to reduce or eliminate snoring and sleep apnea symptoms in adult patients.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Mandibular repositioner; removable dental appliance; custom-fitted via thermal molding (boiling).

Indications for Use

Indicated for adult patients for the reduction or elimination of snoring and obstructive sleep apnea.

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

• Respironics Silencer (K954530)

Submission Summary (Full Text)

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# 长033822

#### FEB - 6 2004 TAB 3

## 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

| Official Contact | Zita A. Yurko<br>Manager, Regulatory Affairs/Product Assurance<br>Respironics, Inc.<br>1001 Murry Ridge Lane<br>Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120<br>724-387-4206 (fax)<br>Email: [e-mail] |
| Classification Reference | 21 CFR 872.5570 |
| Product Code | LRK - Anti-Snoring Device |
| Common/Usual Name | Oral Appliance |
| Proprietary Name | Respironics Custom I Oral Appliance |
| Predicate Device(s) | Respironics Silencer (K954530) |
| Reason for submission | Modified design. |

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#### Substantial Equivalence

The modified device has the following similarities to the previously cleared predicate devices:

- Same intended use. ය
- a Same operating principle.
- Same technology. c
- Same manufacturing process.

Design verification tests were performed on the Respironics Custom I Oral Appliance as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate devices.

The modified device complies with the "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA," November 2002.

#### Intended Use

The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.

#### Device Description

The Respironics Custom I Oral Appliance is a mandibular repositioner that is a removable dental device that is fitted in the patient's mouth that and is indicated to treat patients who snore and patients who have obstructive sleep apnea. The Custom I Device is fit by a trained dentist. The device is fit by boiling the device then custom fitting it into the patient mouth by biting on the device. Like its predicate, the Silencer (K95430), the Custom 1 Oral Appliance is intended to treat patients who snore and who have obstructive sleep apnea.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 6 2004

Respironics, Incorporated Mr. Zita A. Yurko Manager, Regulatory Affairs Home Care Division 1001 Murry Ridge Lanc Murrysville, Pennsylvania 15668-8550

Re: K033822

Trade/Device Name: Respironics Custom I Oral Appliance Regulation Number: 872.5570 Regulation Name: Intraoral Devices For Snoring and Intraoral Deices For Snoring And Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: January 5, 2004 Reccived: January 7, 2004

Dear Mr. Yurko:

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 such additional controls. Existing major regulations affecting your device can be found in the Code of Fedcral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the liederal Register.

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Page 2 - Mr. Yurko

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. or the rect of any a 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 and insting (21 cm forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements 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) Print reter with ation. 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), n from a 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 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 vours,

Ouls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K033822

Page _ 1_ of_ 1

510(k) Number (if known): K033822

Device Name: Respironics Custom 1 Oral Appliance

### Intended Use/Indications for Use

The Respironics Custom I Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring and obstructive sleep apnea.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use (Optional Format 1-2-96) (Per 21 CFR 801.109)

Susan Runov

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev

510(k) Number. 12033822