(58 days)
K95430
No
The summary describes a physical dental appliance and makes no mention of AI, ML, or any software-based analysis or processing.
No.
The device is intended for the reduction or elimination of snoring, which is a symptom and not explicitly described as a disease or condition that requires therapy.
No
Explanation: The device is described as a "mandibular repositioner" intended to reduce or eliminate snoring, not to diagnose a condition. It treats a symptom rather than identifying a disease or condition.
No
The device description clearly states it is a "removable dental device that is fitted in the patient's mouth," indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as an aid for the reduction or elimination of snoring." This is a physical treatment applied to the patient's mouth.
- Device Description: The device is a "mandibular repositioner" and a "removable dental device that is fitted in the patient's mouth." This describes a physical appliance used for a mechanical purpose.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are specifically designed for this purpose.
- Treatment vs. Diagnosis: The device is intended to treat snoring, not to diagnose a condition.
Therefore, the Respironics Custom II Oral Appliance falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth
Indicated Patient Age Range
adult patients
Intended User / Care Setting
dentist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respironics Silencer (K954530)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
ので、その他の一般になっている。
Fremarket Notification – Special 510(k)
TAB 3
FEB - 6 2004
1
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Official Contact | Zita A. Yurko
Manager, Regulatory Affairs/Product Assurance
Respironics, Inc.
1001 Murry Ridge Lane
Murrysville, PA 15668 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | 724-387-4120
724-387-4206 (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. |
1
and the country of the country of the country of the count
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.
2
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.
3
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
4
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