(58 days)
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.
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.
The acceptance criteria and study proving the device meets them are described as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No impact on the safety and effectiveness of the device due to modifications. | Design verification tests were performed and all tests were verified to meet the required acceptance criteria. The modifications have no impact on the safety and effectiveness of the device. |
| Compliance with "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA," November 2002. | The modified device complies with this guidance document. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document does not specify a separate test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study. The summary references "design verification tests" as the basis for meeting acceptance criteria related to safety and effectiveness. This suggests an engineering or bench testing approach rather than a clinical trial with human subjects for efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. The document does not describe a clinical study involving ground truth established by experts for a test set. The evaluation seems to be based on design verification.
4. Adjudication Method for the Test Set:
Not applicable. There is no mention of an adjudication method as no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or a comparison of human readers with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. The device is a physical oral appliance, not an algorithm or AI system. Therefore, a standalone algorithm performance study is irrelevant.
7. Type of Ground Truth Used:
The ground truth for demonstrating device performance appears to be based on successful completion of design verification tests which confirm the device's functional integrity and that modifications had no impact on safety and effectiveness. This is implicit rather than an explicitly stated ground truth for clinical efficacy.
8. Sample Size for the Training Set:
Not applicable. The device is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a device of this nature.
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长033822
FEB - 6 2004 TAB 3
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. YurkoManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668 |
|---|---|
| 724-387-4120724-387-4206 (fax)Email: Zita.Yurko@Respironics.com | |
| 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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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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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
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
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.(b)
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.”