(86 days)
None
No
The device description and performance studies focus on the physical design and clinical efficacy of a pillow, with no mention of AI/ML technologies or data processing.
Yes
The device is intended for the reduction of symptoms associated with mild obstructive sleep apnea, which indicates a therapeutic purpose.
No.
The "PillowPositive Cervical Pillow" is described as a device intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep. It is a therapy device, not a diagnostic one.
No
The device description clearly states it is a physical pillow made of urethane and memory foam, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- PillowPositive's Function: The PillowPositive is a physical device (a pillow) that is used externally to support the head and neck during sleep. Its intended use is to physically maintain an open airway, not to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, laboratory procedures, or diagnostic analysis of bodily fluids or tissues.
The PillowPositive is a therapeutic device intended to alleviate symptoms of a medical condition through physical positioning.
N/A
Intended Use / Indications for Use
PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep.
PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
Product codes
IQK, MYB
Device Description
The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head and neck; upper airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
LifeSleep sponsored a pilot study and a pivotal study to assess the PillowPositive's use in the reduction of symptoms associated with mild obstructive sleep apnea. The pilot study showed a statistically significant reduction in the Respiratory Disturbance Index (i.e., apneas and hypopneas) among subject with mild obstructive sleep apnea.
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)
LifeSleep sponsored a pilot study and a pivotal study to assess the PillowPositive's use in the reduction of symptoms associated with mild obstructive sleep apnea. The pilot study showed a statistically significant reduction in the Respiratory Disturbance Index (i.e., apneas and hypopneas) among subject with mild obstructive sleep apnea. The pivotal study indicated that the PillowPositive produces a statistically significant reduction in subject's Respiratory Disturbance Index, a key indicator of sleep apnea, in subjects with mild sleep apnea.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Respiratory Disturbance Index (i.e., apneas and hypopneas)
Predicate Device(s)
K990871, Dr. Jonathan A. Parker's PM Positioner, Adjustable PM Positioner, Ortho-Rest Company's A-Just Right Pillow
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined strands and a pair of wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 9 2004
Life Sleep Systems, Inc. c/o Mr. Howard M. Holstein Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109
Re: K990871
Trade/Device Name: PillowPositive Cervical Pillow Regulation Number: 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: MYB Dated: March 16, 1999 Received: March 16, 1999
Dear Mr. Holstein:
This letter corrects our substantially equivalent letter of June 10, 1999 regarding the PillowPositive regulatory classification. At the time of that letter. FDA incorrectly classified the Cervical Pillow, as indicated, as an unclassified device. This device is classified under 872.5570, Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea. The product code will remain as MYB.
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 (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 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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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 continue 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 (240) 276-0115. 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.
A. Joseph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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JUN 1 0 1999
(990871
510(K) SUMMARY FOR LIFESLEEP SYSTEMS, INC.'S PILLOWPOSITIVE
Submitter's Name, Address, Telephone Number, and Contact Person
LifeSleep Systems, Inc. 400 Oyster Point Boulevard Suite 112 South San Francisco, California 94080
| Contact: | Anthony A. DiTonno |
|---|---|
| President & Chief Executive Officer | |
| LifeSleep Systems, Inc. | |
| Phone: | (650) 616-9933 / (650) 616-1005 |
| Facsimile: | (650) 616-9930 |
Date Prepared
March 16, 1999
Name of the Device
LifeSleep PillowPositive Cervical Pillow
Common or Usual Name
Cervical Pillow
Classification Name
Truncal Orthosis
Product Code
IQK
Predicate Devices
Lifesleep System's Pillow
Positive Cervical Pillow
3
(4) Ortho-Rest Company's A-Just Right Pillow
Intended Use
PillowPositive Cervical Pillow ("PillowPositive") is intended for the reduction of symptoms (apnea/hypopnea) associated with mild obstructive sleep apnea by maintaining an open upper airway during sleep.
Principles of Operation
The PillowPositive places and holds the head and neck in a position that is similar to that used in cardiopulmonary resuscitation, the upper airway remains open, thereby reducing the incidence of mild obstructive sleep apnea.
Technological Characteristics
The pillow consists of a custom-fitted high resiliency urethane foundation, an overlying "memory foam" supporting the head and neck, a stretch terry-cloth cover, and removable foam inserts. The PillowPositive is comprised of a thin central area for supine sleeping and two thicker, sloped side panels with earwells for side sleeping.
Performance Data
LifeSleep sponsored a pilot study and a pivotal study to assess the PillowPositive's use in the reduction of symptoms associated with mild obstructive sleep apnea. The pilot study showed a statistically significant reduction in the Respiratory Disturbance Index (i.e., apneas and hypopneas) among subject with mild obstructive sleep apnea. The pivotal study indicated that the PillowPositive produces a statistically significant reduction in subject's Respiratory Disturbance Index, a key indicator of sleep apnea, in subjects with mild sleep apnea.
Summary of the Basis for the Finding of Substantial Equivalence
The LifeSleep PillowPositive for the reduction of the symptoms associated with mild obstructive sleep apnea has the same intended use as the Dr. Jonathan A. Parker's PM Positioner, and Adjustable PM Positioner. The Pillow Positive for the reduction of symptoms associated with mild sleep apnea has similar principles or operation as the PM Positioner, the Adjustable PM Positioner, and the A-Just Right Pillow. The PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea has the same technological characteristics as the legally marketed PillowPositive for snoring and very similar technological features as Ortho-Rest Company's A-Just Right Pillow. The minor differences between the intended use and
4
the technological characteristics of LifeSleep's PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea and its predicate devices present no new issues of safety and effectiveness. Moreover, the clinical data demonstrate that the device reduces the symptoms (apneas/hypopneas) associated with mild obstructive sleep apnea. Therefore, the LifeSleep PillowPositive for the reduction of symptoms associated with mild obstructive sleep apnea is substantially equivalent to its legally marketed predicate devices.
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: LifeSleep Systems, Inc. PillowPositive Cervical Pillow
Indications for Use:
PillowPositive Cervical Pillow ("PillowPositive") is indicated for the reduction of symptoms (apneas and hypopneas) associated with mild obstructive sleep apnea.
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(PLEASE DO NOT WRITE BELOW THIS LINE -- CONSINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K990871 |
| 6/9/99 |
Prescription Use __ (Per 21 C.F.R. 801.109)
OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)