(244 days)
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The PureSleep device has three adjustments for forward mandibular advancement, 4mm apart anteriorly, while maintaining a 9mm inferior placement for patient comfort. The PureSleep device is formed to the upper and lower teeth similar to an athletic mouth guard. When boiled, the outer resin holds its shape, while the inner resin softens, which adapts to the teeth when bitten. To prepare for the fitting, the upper and lower components are attached at the proper setting depending on the patient's bite, using either the two holes closest to the front of the device, the center holes, or the two holes closest to the back of the device. The device is boiled in water for one minute, allowed to cool for 14 to 18 seconds. Holding the mouth open and lower jaw forward, the patient places the PureSleep device in the mouth and bites down firmly for 45 seconds. Upon removal of the device, excess material can be trimmed for greater comfort. The device can be re-boiled up to three times to achieve the best impression. PureSleep is simple to fit and does not require impressions or lab-fabrication.
The provided K113022 document for the PureSleep device does not contain a study with acceptance criteria or reported device performance in the format typically used for studies demonstrating diagnostic accuracy or efficacy against specific metrics for new medical devices.
Instead, this 510(k) submission primarily relies on substantial equivalence to predicate devices and published literature to support the expanded indications for use.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria for device performance (e.g., sensitivity, specificity for diagnosing sleep apnea, or specific metrics for snoring reduction) nor does it report specific device performance data from a clinical study for these indications.
The key performance information mentioned is:
- Biocompatibility testing: "Biocompatibility testing was performed, according to ISO 10993 Parts 5 and 10, on the proposed device and all tests met specification." This indicates the materials are safe for use, but it's not a performance metric related to the therapeutic effect (snoring or sleep apnea).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No specific test set or clinical study data is presented for the PureSleep device regarding its efficacy in reducing snoring or treating sleep apnea. The submission relies on the "mechanism of action" being unchanged from the predicate device and on "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This implies a reliance on existing literature and clinical evidence for the class of devices, rather than a de novo clinical trial for the PureSleep device itself for these expanded indications.
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 new clinical study data with a test set requiring ground truth establishment by experts is presented for the PureSleep device in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study data with a test set is presented.
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
Not applicable. The PureSleep device is a physical intraoral device, not an AI or imaging diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The PureSleep device is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no new clinical study data with a test set requiring ground truth is presented for the PureSleep device itself. The basis for efficacy for the expanded indications appears to stem from the general understanding and previous studies on mandibular repositioning devices (as indicated by "Published literature and the cleared predicate devices justify the rationale for expanding the intended use to treat mild to moderate obstructive sleep apnea"). For such literature, the ground truth for sleep apnea diagnosis would typically be established by polysomnography interpreted by sleep specialists.
8. The sample size for the training set
Not applicable. This device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI algorithm requiring a training set.
Summary of Acceptance Criteria and Study Approach for K113022:
The K113022 submission for the PureSleep device did not involve a specific clinical study with predefined acceptance criteria and reported performance data for the device itself to evaluate its efficacy for snoring reduction or treatment of mild to moderate obstructive sleep apnea.
Instead, the FDA determined substantial equivalence based on the following:
- Identical Design (with one exception): "With the exception of the molding resin used for the upper intraoral piece, the design of the proposed PureSleep device is identical to the currently marketed PureSleep (formerly known as SnoreMaster K954128)."
- Biocompatibility: The new molding resin met ISO 10993 Parts 5 and 10 specifications, ensuring material safety.
- Unchanged Mechanism of Action: The device's fundamental way of working (mandibular repositioning) remained the same as the previously cleared predicate device.
- Reliance on Published Literature: The expanded indication for treating mild to moderate sleep apnea was justified by "published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea." This means the submission leveraged existing clinical evidence for the class of devices rather than providing new clinical evidence specifically for the PureSleep device's expanded use.
- Substantial Equivalence to Predicates: The sponsor successfully argued that the PureSleep device is substantially equivalent to the currently marketed PureSleep device (K954128) and the SomnoGuard (K061688), both of which are intraoral devices for snoring and obstructive sleep apnea.
In essence, the "study" demonstrating the device meets "acceptance criteria" here is not an individual clinical trial with specific performance outcomes, but rather the demonstration of substantial equivalence to legally marketed predicate devices, supported by general scientific understanding and existing literature on the efficacy of the device type for the stated indications, and direct biocompatibility testing of any new materials.
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JUN 1 1 2012
Section 5.0 510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Sleep Science Partners, Inc. |
|---|---|
| Submitter's Address: | 900 Larkspur Landing Circle, Suite 207Larkspur, CA 94939 |
| Telephone:Fax: | 415-272-7777415-925-1575 |
| Contact Person:Date Prepared: | Heather FlickOctober 7, 2011 |
| Device Trade Name: | PureSleep |
| Device Common Name:Device Classification Name: | Antisnoring deviceIntraoral devices for snoring and obstructive sleep apnea |
| Device Classification: | Class II |
| Product Classification: | 872.5570 |
| Product Code | LRK |
Summary of Substantial Equivalence:
The proposed PureSleep is substantially equivalent to the currently marketed PureSleep device (formerly known as SnoreMaster - K954128) and the SomnoGuard (K061688).
Device Description:
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults. It advances the lower jaw and tongue forward so the airway will remain open during sleep. The PureSleep device has three adjustments for forward mandibular advancement, 4mm apart anteriorly, while maintaining a 9mm inferior placement for patient comfort.
Confidential
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The PureSleep device is formed to the upper and lower teeth similar to an athletic mouth guard. When boiled, the outer resin holds its shape, while the inner resin softens, which adapts to the teeth when bitten. To prepare for the fitting, the upper and lower components are attached at the proper setting depending on the patient's bite, using either the two holes closest to the front of the device, the center holes, or the two holes closest to the back of the device. The device is boiled in water for one minute, allowed to cool for 14 to 18 seconds. Holding the mouth open and lower jaw forward, the patient places the PureSleep device in the mouth and bites down firmly for 45 seconds. Upon removal of the device, excess material can be trimmed for greater comfort. The device can be re-boiled up to three times to achieve the best impression.
PureSleep is simple to fit and does not require impressions or lab-fabrication. As such, it is a more economical and timesaving alternative to more costly lab-fabricated mandibular advancement devices.
Intended Use:
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.
Technological Characteristics Compared to Predicate:
A comparison of the technological characteristics of the proposed PureSleep and the predicate devices has been performed. The results of this comparison demonstrate that the proposed PureSleep device is equivalent to the predicate devices.
Performance Data:
With the exception of the molding resin used for the upper intraoral piece, the design of the proposed PureSleep device is identical to the currently marketed PureSleep (formerly known as SnoreMaster K954128), cleared in October 2, 1995. Biocompatibility testing was performed, according to ISO 10993 Parts 5 and 10, on the proposed device and all tests met specification. The mechanism of action remains the same. Published literature and the cleared predicate devices justify the rationale for expanding the intended use to treat mild to moderate obstructive sleep apnea.
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Published Literature
The PureSleep indications for use have been expanded to include, "treat mild to moderate sleep apnea in adults." This expanded claim is based on the fact that the PureSleep mechanism of action has not changed since the original and cleared FDA product submission K954128 and on published scientific studies that have shown mandibular repositioning devices effective in treating snoring and mild to moderate obstructive sleep apnea.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The text is in all capital letters and is evenly spaced around the circle.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Heather Flick
Vice President and Chief Legal Counsel Sleep Science Partners, Inc. 900 Larkspur Landing Circle, Suite 207 Larkspur, California 94939
Re: K113022
Trade/Device Name: PureSleep Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea
Regulatory Class: II Product Code: - LRK Dated: June 4, 2012 Received: June 7, 2012
Dear Ms. Flick:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register,
JUN 1 1 2012
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Page 2 - Ms. Flick
. Enclosure
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Section 4.0 Indications for Use
510(k) Number (if known): K113022
Device Name: PureSleep
Indications for Use:
PureSleep is an intraoral mandibular repositioning device used during sleep to reduce snoring and treat mild to moderate obstructive sleep apnea in adults.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Sven Ryan
(Division Sign-Off)
Goneurrenee of CDRH, Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113022
Sleep Science Partners, Inc. PureSleep 510(k) October 7, 2011
Confidential
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§ 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.”