(562 days)
The Anti-Snoring Device is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
The Pi Medical Anti-Snoring Device is intended as a treatment option for snoring and consists of an implant and a delivery tool. The Anti-Snoring Device is designed to stiffen the tissue of the soft palate and to reduce the dynamic flutter of those tissues without interfering with the normal function of the soft palate.
The implant is a cylindrical shaped segment of braided polyester filaments. The delivery tool is comprised of a handle and needle assembly that allows for positioning and placement of the implant submucosally in the soft palate. The implant is permanent while the delivery tool is disposable.
The implant is available in a range of lengths, 0.59" to 1.38" and three different diameters: 0.050", 0.064", and 0.087". Corresponding delivery tool sizes are: 16Ga, 14Ga and 12Ga. The different sizes allow the physician to tailor the size of the implant to the patient's anatomy.
This 510(k) summary describes a medical device, the Pi Medical Anti-Snoring Device, which is intended to stiffen the soft palate tissue to reduce snoring. However, the provided document DOES NOT contain the detailed information necessary to answer the questions about acceptance criteria and the specifics of a study proving the device meets those criteria.
The document is a 510(k) summary for regulatory submission, which primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's design, intended use, and general testing categories. It is not an efficacy study report.
Here’s what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Integrity | Met or exceeded requirements |
| Mechanical Performance | Met or exceeded requirements |
| Reliability | Met or exceeded requirements |
| Biocompatibility | Met or exceeded requirements |
| Insertion Ability | Met or exceeded requirements |
| Preclinical Performance | Met or exceeded requirements |
Explanation: The document states, "The Anti-Snoring Device met or exceeded all performance requirements." However, it does not specify what those "requirements" or "acceptance criteria" were (e.g., specific thresholds for dimensional tolerance, force resistance, or biological response).
Missing Information/Not Applicable (based on the provided text):
2. Sample size used for the test set and the data provenance:
- Not provided. The document mentions "preclinical performance" but no details about clinical trial sample sizes, human subject data, or its origin (country, retrospective/prospective). This submission is from 2002, and the focus is on "substantial equivalence" based on physical and performance characteristics, not necessarily clinical efficacy data like modern device submissions might require for certain claims.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "test set" requiring expert ground truthing in the context of clinical efficacy or diagnostic performance. The testing described is primarily engineering/material performance.
4. Adjudication method for the test set:
- Not applicable. No mention of a test set requiring adjudication in the clinical sense.
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. This device is an implantable anti-snoring device, not an AI-powered diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical implant, not a software algorithm.
7. The type of ground truth used:
- Not explicitly stated in the context of clinical efficacy. For the engineering/material performance tests, the "ground truth" would be established by the specifications and standards applied to each test category (e.g., dimensional specifications, mechanical strength standards, biocompatibility protocols). There is no mention of pathology, outcomes data, or expert consensus related to the device's clinical performance. The "preclinical performance" likely refers to bench testing or animal studies, but details are not provided.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that would have a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided 510(k) summary for the Pi Medical Anti-Snoring Device demonstrates that the device underwent various engineering and material performance tests (dimensional, mechanical, reliability, biocompatibility, insertion ability, preclinical) and "met or exceeded all performance requirements." However, the document does not elaborate on the specific acceptance criteria, method, or results for these tests, nor does it present data from a clinical study on human subjects with ground truth for snoring severity, which would be necessary to answer most of your detailed questions. The 510(k) pathway relies on demonstrating substantial equivalence to previously cleared devices rather than requiring extensive de novo clinical efficacy studies in all cases.
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510(k) Summary
DEC 1 8 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K011723.
| SUBMITTER: | Pi Medical, Inc.2800 Patton RoadSt. Paul, MN 55113 |
|---|---|
| CONTACT PERSON: | Edward W. Numainville |
| DATE PREPARED: | December 17, 2002 |
| TRADE NAME: | Pi Medical Anti-Snoring Device |
| COMMON NAME: | Anti-Snoring Device |
| CLASSIFICATION: | 21 CFR Section 874, Ear, Nose & Throat DevicesUnclassified, as are the predicate devices |
| PRODUCT CODE: | LRK |
| PREDICATE DEVICE(S): | Influence, Inc.'s Repose Bone Screw System, cleared via 510(k) K981677 on August 27, 1999 for the treatment of obstructive sleep apnea and/or snoring.Somnoplasty System, manufactured by Somnus Medical Technologies, Inc. and cleared via 510(k) K971450 on July 17, 1997 for reducing the severity of snoring in some individuals. |
| DEVICE DESCRIPTION: | The Pi Medical Anti-Snoring Device is intended as a treatment option for snoring and consists of an implant and |
| a delivery tool. The Anti-Snoring Device is designed tostiffen the tissue of the soft palate and to reduce thedynamic flutter of those tissues without interfering with thenormal function of the soft palate.The implant is a cylindrical shaped segment of braidedpolyester filaments. The delivery tool is comprised of ahandle and needle assembly that allows for positioning andplacement of the implant submucosally in the soft palate.The implant is permanent while the delivery tool isdisposable.The implant is available in a range of lengths, 0.59" to1.38" and three different diameters: 0.050", 0.064", and0.087". Corresponding delivery tool sizes are: 16Ga, 14Gaand 12Ga. The different sizes allow the physician to tailorthe size of the implant to the patient's anatomy. | |
| INTENDED USE: | The Anti-Snoring Device is intended for use instiffening the soft palate tissue which may reduce theseverity of snoring in some individuals. |
| EQUIVALENCE TESTING: | The Anti-Snoring Device has been tested fordimensional integrity, mechanical performance andreliability, biocompatibility, insertion ability andpreclinical performance. The Anti-Snoring Device metor exceeded all performance requirements. |
| CONCLUSION: | The Pi Medical Anti-Snoring Device is substantiallyequivalent to the Repose Bone Screw System (K981677) inits product code, intended use, design, materials and its use ofa permanent implant to address snoring problems. Inaddition, the Anti-Snoring Device is substantially equivalentto the Somnoplasty System (K971450) in its intended use,target population, design, function, and approach to snoringmanagement. Testing demonstrates the device performs asanticipated and raises no new questions of safety andeffectiveness over the predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing right, stacked one above the other, creating a sense of depth and unity.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Edward W. Numainville Vice President, Regulatory and Clinical Affairs P I Medical, Incorporated 2800 Patton Road Saint Paul. Minnesota 55113
Re: K011723
Trade/Device Name: Anti-Snoring Device Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LRK Dated: October 25, 2002 Received: October 28, 2002
Dear Mr. Numainville:
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 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. Numainville
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. 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), please contact the Office of Compliance at (301) 594-4613 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
Patricia Cuantiffor
Timothy A. Ulatowski 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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510(k) Number (if known):__K011723
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Anti-Snoring Device is intended for use in stiffening the soft palate tissue which may reduce the severity of snoring in some individuals.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rupp
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: kca1/729
§ 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.”