(183 days)
The intended use of the "Oxi-Snap" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The Oxi-SNAP testing system is only intended for short term monitoring such as to record the oximetry level continuously during the night.
The "Oxi-SNAP" system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.
The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
This notification is for a modification to the existing device, the "Snap Testing Device" the modified device is called the "Oxi-Snap" The modification involves the addition of the ability to record and analyze, (along with snoring sounds) the oxygen saturation level of the patient being monitored. An FDA cleared oximeter (Palco Model K943842) is connected to the currently used DAT tape 305, recorder, and the oxygen saturation is recorded while the patient is under test. Later, during the analysis phase, O2 SAT levels appear on the playback analysis screen, thereby allowing an additional criterion of apnea to be used.
The provided text [K971184](https://510k.innolitics.com/device/K971184) is a 510(k) summary for the "Oxi-Snap" device, which is a modification of an existing device ("Snap Testing Device") to include oxygen saturation level recording and analysis. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove the device meets those criteria in a typical stand-alone performance study format.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) for detecting apnea or snoring. Instead, it relies on demonstrating that the modified device ("Oxi-Snap") is as safe and effective as its predicate devices, primarily the "Snap Testing Device" (K944524), and incorporates an FDA-cleared oximeter (Palco Model 305, K943842).
The "Performance Testing" section in the Substantial Equivalence Chart for the "Oxi-SNAP" states "Summarized above," referring to the general conclusion of safety and effectiveness presented earlier. For the predicate "SNAP testing device," it refers to "Original submission," implying detailed performance data was provided in its initial filing.
Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported performance metrics directly from this document. The "acceptance criteria" here are fundamentally about demonstrating substantial equivalence and maintaining the safety and effectiveness of the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| As safe and effective as predicate devices (K944524) | "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device" |
| Provides additional benefit of oxygen saturation level information | "provides the additional benefit of giving the clinician more information about the patient's snoring and apnea condition. The additional information is the patient's oxygen saturation level." |
| Easy for user to set up | "The modified device is easy for the user to set up at home or in the sleep laboratory." |
| Compliance with electrical safety and EMI standards | "ETL Listed," "Per applicable sections of UL-2601," "Per FCC Part 15 Class A" |
| Oximetry functionality included | "Included" (referencing the Palco oximeter) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and user testing" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention using experts to establish ground truth for a test set. This type of study design for determining diagnostic accuracy with expert-derived ground truth is not described in this 510(k) submission, which focuses on substantial equivalence.
4. Adjudication Method for the Test Set
Since no expert-established ground truth study is described, no adjudication method is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No MRMC comparative effectiveness study is described in this 510(k) summary. The document focuses on the technical modification of the device and its claimed equivalence to existing devices. Its purpose is not to demonstrate improvement over human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The "Oxi-Snap" system is described as an "analyser service center" where tapes are analyzed, implying a human-in-the-loop for interpreting the recorded data. However, the core of the submission is about the device's ability to record and present data, not a standalone AI algorithm producing diagnoses. The Palco Model 305 oximeter, which is incorporated, would have undergone standalone performance testing as a prerequisite for its own FDA clearance (K943842). The Oxi-Snap itself is an analysis system that presents data.
7. The Type of Ground Truth Used
The document does not explicitly describe a ground truth used for performance evaluation of "Oxi-Snap" similar to what would be found in a diagnostic accuracy study. The "effectiveness" is primarily assessed by its ability to record and provide additional information (oxygen saturation) in a manner comparable to its predicate and the incorporated cleared oximeter. Polysomnography (PSG) is often considered the gold standard for sleep apnea diagnosis, and the document states the Oxi-SNAP system is "not intended as a substitute for full polysomnography." This suggests that while it screens for apnea, its "ground truth" for screening performance is likely benchmarked against clinical utility as a screening tool, not necessarily against a definitive PSG diagnosis within this specific filing.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is not an AI/machine learning device in the contemporary sense, but rather a modification to a recording and analysis system.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, no information is provided on how its ground truth would have been established.
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APPENDIX 3
SNAP Laboratories, LLC 3633 West Lake Avenue, Suite 406 Glenview, IL 60025 USA OCT - 1 1997 847-657-8100 Fax: 847-657-8105 Contact Name: Gil Raviv, President March 28, 1997
510 (k) Summary of Safety and Effectiveness
-
- Identification of the Device Proprietary-Trade Name: "Oxi-Snap" Classification Name: Apnea/Snoring Recording and Analysis Device and Oximeter. Common/Usual Name: Snoring and Apnea Recording and Analysis Device.
-
- Indications for Use: The intended use of the "Oxi-Snap" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The Oxi-SNAP testing system is only intended for short term monitoring such as to record the oximetry level continuously during the night.
The "Oxi-SNAP" system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.
The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
- র্ব -Description of the Device: This notification is for a modification to the existing device, the "Snap Testing Device" the modified device is called the "Oxi-Snap" The modification involves the addition of the ability to record and analyze, (along with snoring sounds) the oxygen saturation level of the patient being monitored. An FDA cleared oximeter (Palco Model K943842) is connected to the currently used DAT tape 305, recorder, and the oxygen saturation is recorded while the patient is under test. Later, during the analysis phase, O2 SAT levels appear on the playback analysis screen, thereby allowing an additional criterion of apnea to be used.
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-
- Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device and provides the additional benefit of giving the clinician more information about the patient's snoring and apnea condition. The additional information is the patient's oxygen saturation level. The modified device is easy for the user to set up at home or in the sleep laboratory. The modification involves the addition of a portable oximeter to the patient setup. The oximeter is connected to the DAT tape recorder along with the usual microphone/cannula apparatus and the oximeter sensor is slipped over the patient's finger in the usual manner. The patient turns on the tape recorder, then goes to sleep. Apnea and snoring events are then recorded. After awakening, the patient returns the tape and the equipment to the analysis service center, where the tape is analyzed.
6. Substantial Equivalence Chart - Appendix 2
7 . Conclusion
After analyzing both bench and user testing data, it is the conclusion of SNAP Laboratories that the "Oxi-Snap" testing snoring and apnea testing device is as safe and effective as the predicate device and has no new indications for use, thus rendering it substantially equivalent to the predicate Snap Testing Device.
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Substantial_Equivalence_Chart
| Characteristic | Predicate device: SNAPtesting device (K944524) | Modified device:"Oxi-SNAP" | Palco (K943842) | Mesam IV(K901466) |
|---|---|---|---|---|
| Labeling: | (Original submission) | The User's manualhas been updatedto include adescription ofthe oximetrydevice | Oximetry diagnostics | Apnea &SnoringDiagnostics |
| Intended Use: | Recording and analysisof snoring and apnea | Recording andanalysis ofsnoring and apnea | Recording & Analysisof oximetry | Recording andanalysis ofsnoring & apnea |
| Physical Charac-teristics: | ||||
| Recording device: | Sony TDC-D7 DAT digitalaudio tape recorder | Sony TDC-D7 DATdigital audiotape recorder | Oximeter | Recorder (solidstate) |
| Channels acquired: | One: snoring soundsrecorded by microphone | Two: snoringsounds on onechannel,Oximetry level onthe other channel | Oximetry and pulserate | SnoringOxygen Satur-ationBody PositionEvent MarkingHeart rate |
| User equipment: | DAT recorder, tape,cannula, microphone | DAT recorder, tape,cannula, mic-rophone, andOximéter, PalcoModel 305 | OximeterFinger Probe | RecorderSensors |
| Energy Source: | 120 V 60-wall mountAC-DC converter 12W(recommended) orbatteries | 120 V 60-wallmount AC-DC con-verter 12W (rec-ommended) orbatteries Plus | Battery or 120V60 V wall mount | Battery |
| Anatomical Sites: | Upper lip | NiCad rechargeablebatteries for theoximeter (12 hourlife per charge)Charger is UL list | Finger probe | Finger probe- Microphoneattached topatient neck- Chest sensorsfor body posit-ion and EKG. |
| PerformanceTesting | Originalsubmission | Summarized above | ClinicalEvaluation | Unknown to us |
| SafetyCharacteristics: | ETL Listed | ETL Listed | CSA - testedfor UL 544 | Unknown to us |
| ElectricalSafety: | Per applicable sectionsof UL-2601 | Per applicable sec-tions of UL-2601 | CSA for UL.544& IEC601-1 | Unknown to us |
| EMI: | Per FCC Part 15-Class A | Per FCC Part 15Class A | Yes, EN55011BGroupEN60601-1-2 | Unknown to us |
| Oximetry | Not included | Included | Included | Included |
| Intended Popula-tion | Older than 3 yrs. old | Adults and pediat-rics | Adults andpediatrics | Believe thatadults andpediatrics |
,
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Characteristic Predicate device: SNAP Modified device: Palco (K943842) testing device (K944524) "Oxi-SNAP" Mesam IV (K901466)
As the Palco Part List (andress) indicated, the Palco sensors list (an accessory to the NOTE : Palco Oximeter) includes a Pediatric Sensor.
Yes (by Health-
care Profess-
ional)
Yes
Yes
Home Use
Yes
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "SERVICES • USA" are written above the eagle. The words "DEPARTMENT OF HEALTH" are written in a circular fashion around the left side of the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 1 1997
Gil Raviv, Ph.D. SNAP Laboratories, L.L.C. 3633 West Lake Avenue, Suite 406 Glenview, Illinois 60025
K971184 Re: "OXI-SNAPTM" Regulatory Class: II (two) Product Code: 73 MNR Dated: July 1 1997 Received: July 8 1997
Dear Dr. Raviv:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Gil Raviv, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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II Indications for Use
510(k) Number K971184.
Device Name: "Oxi-Snap" Snoring and Apnea recording and analysis system.
Indications for Use:
-
- C.
The intended use of the "Oxi-Snap" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
Oxi-SNAP testing system is only intended for short term The monitoring such as to record the oximetry level continuously during the night .
The "Oxi-SNAP" system is not intended as a substitute for full limb movements were additional parameters such as sleep stages, limb movements or BEG activity are required.
The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Oxi-Snap device.
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, Division of Neurological Devices Prescription Use OR Overstine Wa inter Uge _ (Per 21 CFR 801.109)
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).