(58 days)
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.
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.
The provided text is a 510(k) Summary for a medical device called the "Respironics Custom II Oral Appliance." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document states: "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." But it does not list what those specific acceptance criteria were, what the reported device performance was against those criteria, or details about the studies conducted.
Here's a breakdown of what I can answer based on the provided text, and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
| (The document only states "All tests were verified to meet the required acceptance criteria." It does not detail what those criteria were or the specific performance metrics achieved.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified in the document.
- Data provenance: Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no specific human expert evaluation study is described for ground truth establishment. The device is a physical appliance, not an AI or diagnostic tool requiring ground truth from experts for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific human expert evaluation study for ground truth is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This device is an oral appliance for snoring, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical oral appliance, not an algorithm. Therefore, "standalone performance" in the context of an algorithm is not relevant. The device itself is the "standalone" product that is fitted by a dentist.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified. For a physical device like this, "ground truth" would typically relate to objective measures of effectiveness (e.g., reduction in snoring events, patient comfort, retention) from clinical studies. The document only mentions "design verification tests" were performed.
8. The sample size for the training set
- Not applicable. This device is a physical oral appliance, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical oral appliance, not an AI algorithm that requires a training set.
Summary of what the document does state regarding performance/testing:
The submission states that "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." This indicates that internal testing was conducted to ensure the device met its design specifications and safety requirements. However, the specifics of these tests, the acceptance criteria, and the results are not detailed in this summary document. The focus of this 510(k) is on demonstrating substantial equivalence to a predicate device, primarily based on intended use, operating principle, technology, and manufacturing process.
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Fremarket Notification – Special 510(k)
TAB 3
FEB - 6 2004
1
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 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 (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 my obtain 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 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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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.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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
§ 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.”