RESPIRONICS CUSTOM II ORAL APPLIANCE

K033823 · Respironics, Inc. · LRK · Feb 6, 2004 · Dental

Device Facts

• Record ID: K033823
• Device Name: RESPIRONICS CUSTOM II 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 II Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring.

Device Story

Respironics Custom II Oral Appliance is a removable mandibular repositioner; fitted in patient's mouth by a trained dentist. Device is custom-fit via a boil-and-bite process. Functions as an oral appliance to treat snoring. Used in a dental clinical setting. Output is the physical positioning of the mandible to maintain airway patency during sleep, reducing snoring. Benefits patient by providing a non-invasive aid for snoring reduction.

Clinical Evidence

Bench testing only. Design verification tests were performed based on risk analysis and product requirements to confirm the device meets acceptance criteria.

Technological Characteristics

Mandibular repositioner; removable dental appliance. Custom-fit via boil-and-bite thermoplastic material. Mechanical operation; no energy source. Non-networked, standalone device.

Indications for Use

Indicated for adult patients to aid in the reduction or elimination of snoring.

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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Fremarket Notification – Special 510(k)

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FEB - 6 2004

K033823

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# 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 II 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. ට
- D Same operating principle.
- Q Same technology.
- D Same manufacturing process.

Design verification tests were performed on the Respironics Custom II 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 II Oral Appliance is intended for use by a dentist on adult patients as an aid for the reduction or elimination of snoring.

### Device Description

The Respironics Custom II 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. The Custom II Device is fit by a trained dentist. The device is fit by boiling the custom fitting it into the patient mouth by biting on the device. Like its predicate, the Silencer (K95430), the Custom II Oral Appliance is intended to treat patients who snore.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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 Lane Murrysville, Pennsylvania 15668-8550

Re: K033823

Trade/Device Name: Respironics Custom I 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 Received: 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 prodicate 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 approvisions 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 cither 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal 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 incan that 1171 mas made statutes and regulations administered by other Federal agencies. of the Act of any I edentifical the Act step.
You must comply with all the Act 's requirements, including, but not limited to: registration 1 ou inual compry with as 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (2) CFR Part 807), agestems (QS) regulation (21 CFR Part 820); and if Itequirements as set form in the quarty and 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) I mis letter will anon your of substantial equivalence of your device to a premaired predicate in - 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 you desire spective at 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 my obtain 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,

Cun Ps

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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K033823

510(k) Number (if known): K033823

Device Name: Respironics Custom II Oral Appliance

### Intended Use/Indications for Use

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use (Optional Format 1-2-96)

Suresh Kumar

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Ountral Dental Devices Division of Control, Dental De

510(k) Number: KC033823