(187 days)
The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The 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. CAUTION: US Federal law 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 "Digi-Snap™" device.
This notification is for a modification to the existing device, the "Oxi-Snap™" Testing Device. The modified device is called the "Digi-Snap. TM" The modification involves the use of a 100 MB "Zip" drive in place of the DAT tape recorder. This eliminates one A/D-D/A conversion because the snoring sounds are digitized at the first opportunity, in the unit at the patient's bedside.
The provided text does not contain any specific acceptance criteria or performance metrics for the "Digi-Snap TM" device. The submission is for a modification to an existing device, focusing on substantial equivalence to a predicate device rather than presenting new clinical study data with detailed performance outcomes against predefined criteria.
The document primarily describes:
- Device Identification: The "Digi-Snap TM" device, its classification, and common name.
- Predicate Device: "Oxi-Snap TM" Testing Device (K971184).
- Intended Use: Screening patients for apnea and snoring, providing quantitative and qualitative analysis, short-term monitoring, not a substitute for full polysomnography.
- Description of Modification: Replacement of a DAT tape recorder with a 100 MB "Zip" drive for digital recording.
- Substantial Equivalence Chart: Compares characteristics of the modified device to the predicate device, highlighting changes in recording device, channels acquired, user equipment, and energy source.
- Conclusion: The device is deemed as safe and effective as the predicate device based on "bench and user testing data," achieving substantial equivalence.
- FDA Clearance Letter: Confirms substantial equivalence finding.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's an attempt to answer based on the available information, explicitly stating when data is not provided:
Acceptance Criteria and Device Performance Study Information for "Digi-Snap TM"
The provided 510(k) submission for the "Digi-Snap TM" device focuses on demonstrating substantial equivalence to a predicate device ("Oxi-Snap TM," K971184) due to a modification (replacing a DAT tape recorder with a Zip drive). It emphasizes that the modified device is "as safe and effective" as the predicate based on "bench and user testing." However, no specific quantitative acceptance criteria or detailed performance results from a clinical study are provided in this document to directly populate the requested table or answer most detailed questions about device performance against such criteria.
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or corresponding reported device performance metrics are provided in the document. The submission states that "The results of bench and user testing indicates that the modified device is as safe and effective as the predicate device." This is a qualitative statement of equivalence rather than a report on specific performance metrics against defined criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not provided. The document mentions "bench and user testing" but gives no details on the number of subjects or cases included in these tests.
- Data Provenance: Not specified, but given the context of US regulatory submission by a US company (Glenview, IL), it can be inferred that testing would likely have taken place in the US. The document does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not provided. Details about how "user testing" was conducted, who assessed the results, or the qualifications of any involved experts are absent.
4. Adjudication Method for the Test Set
Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not indicated. The document focuses on device modification and equivalence, without suggesting a comparative effectiveness study involving human readers with and without AI assistance.
6. Standalone Performance Study
The submission indicates "bench and user testing," but no specific standalone performance study report with detailed metrics (e.g., sensitivity, specificity for apnea detection) is included in the provided text. The focus is on demonstrating that the modified component (Zip drive for recording) does not compromise the overall safety and effectiveness established by the predicate device.
7. Type of Ground Truth Used
Not explicitly stated. Given the device's purpose (screening for apnea and snoring), the "user testing" likely involved comparisons to established methods of diagnosing these conditions (e.g., polysomnography or other clinical assessments), but this is not detailed in the document.
8. Sample Size for the Training Set
Not applicable. This device is a recording and analysis system, not an AI/machine learning algorithm that typically requires a training set. The modification described is a hardware change (recording medium).
9. How the Ground Truth for the Training Set Was Established
Not applicable (as it's not an AI/ML device with a training set).
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EXHIBIT 2
Snap Laboratories, LLC 3633 West Lake Avenue Suite 406 Glenview. IL 60025 USA 847-657-8100 Fax: 847-657-8105 Contact Name: Gil Raviv, President February 21 1999
510(k) Summary of Safety and Effectiveness
-
- Identification of the Device Proprietary-Trade Name: "Digi-Snap TM" Classification Name: 73 MNR Apnea/Snoring Recording and analysis Device and 74DQA, Oximeter. Common/Usual Name: Snoring and Apnea Recording and Analysis Device
-
- The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The 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. CAUTION: US Federal law 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 "Digi-Snap™" device.
-
- Description of the Device: This notification is for a modification to the existing device, the "Oxi-Snap™" Testing Device. The modified device is called the "Digi-Snap. TM" The modification involves the use of a 100 MB "Zip" drive in place of the DAT tape recorder. This eliminates one A/D-D/A conversion because the snoring sounds are digitized at the first opportunity, in the unit at the patient's bedside.
-
- 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
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device. The modified device is easy for the user to set up at home or in the sleep laboratory. The modification involves the use of a fully digital recording technique. The oximeter is connected to the unit 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 unit, then goes to sleep. Apnea and snoring events are then recorded. After awakening, the patient returns the disk and the equipment to the analysis service center, where the disk is analyzed.
-
- Substantial Equivalence Chart
| Characteristic | Predicate device: Oxi-SNAPTM testing deviceK971184 | Modified device:"Digi-Snap TM" |
|---|---|---|
| Labeling: | (Original submission) | The User's Manual has beenupdated to show the newconfiguration, with new operationinstructions. |
| Intended Use: | Recording and analysis of snoringand apnea | Same |
| Physical characteristics: | ||
| Recording device: | Sony TDC-D7 DAT digital audiotape recorder | 100 MB "Zip" Drive andproprietary interface. |
| Channels acquired: | Two: snoring sounds on onechannel, Oximetry level on theother channel. | Three: snoring sounds, Oximetrylevel, and Heart Rate |
| User equipment: | DAT recorder, tape, cannula,microphone, and Oximeter, PalcoModel 305 | Zip unit, Zip Disk, cannula,microphone, and Oximeter, NoninOEM II or Xpod. |
| Energy Source: | 120 V 60~wall mount AC-DCconverter 12W (recommended) orbatteries Plus NiCad rechargeablebatteries for the oximeter (12 hourlife per charge) Charger is ULlisted | 90-240 V, 50/60~ internal Medicalgrade power supply |
| Anatomical sites: | Upper lip and finger probe | Same |
| Performance testing: | Summarized above | Same |
| Safety characteristics: | ||
| Electrical safety: | Per applicable sections of UL-2601 | Same |
| EMI: | Per FCC part 15 Class A | FCC class B, CISPR 11 Class B |
| Oximetry | Included | Same |
| Intended population | Adults and pediatrics | Same |
| Home use | Yes | Same |
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Snap Laboratories that the "Digi-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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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 1999
Gil Raviv, Ph.D. Snap Laboratories 3633 West Lake Avenue, Suite 406 Glenview, IL 60025
Re: K984169 "Digi-Snap™" Snoring and Apnea Recording and Analysis Device Regulatory Class: II (two) Product Code: 73 MNR February 23, 1999 Dated: February 26, 1999 Received:
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 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). 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 requlatory 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. C allahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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i) Indications for Use
K984169 510(k) Number
Device Name: "Digi-Snap ™" Snoring and Apnea recording and analysis system
Indications for Use:
The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The 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.
CAUTION: US Federal law 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 "Digi-Snap TM" device.
Concurrence of CDRH, Office of Device Evaluation (ODE)
R.H.A. Garlurchi.
Prescription Use / _ OR Over the Counter Use _
(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).