(183 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on adding oximetry data to an existing recording and analysis system.
No.
The "Oxi-Snap" device is described as a screening and monitoring tool for apnea and snoring, providing diagnostic information (quantitative and qualitative analysis of apnea and snoring, and oxygen saturation levels), rather than providing therapy or treatment.
Yes
The device is intended to "screen patients for apnea and snoring" and provides "quantitative and qualitative analysis of apnea and snoring," which are diagnostic activities. It records oximetry levels and allows "additional criterion of apnea to be used" for analysis.
No
The device description explicitly states that the modification involves connecting an FDA cleared oximeter (Palco Model K943842) to a DAT tape recorder (DAT tape 305). This indicates the device includes hardware components (oximeter and recorder) in addition to the software for analysis.
Based on the provided information, the "Oxi-Snap" device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Oxi-Snap device directly monitors physiological parameters (snoring sounds, oxygen saturation, body position, EKG) from the patient's body. It does not analyze samples like blood, urine, or tissue.
- The intended use is direct patient monitoring and screening. The device is used to screen patients for apnea and snoring by recording and analyzing physiological signals in real-time or near real-time. This is a form of physiological monitoring, not in vitro analysis.
- The device description confirms direct patient connection. The description mentions a microphone attached to the neck, chest sensors, and a finger probe for the oximeter, all of which are directly connected to the patient.
Therefore, the Oxi-Snap device falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
73 MNR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper lip
Finger probe
Indicated Patient Age Range
pediatric and adult patients
Intended User / Care Setting
The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory.
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
-
- 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.
2
Substantial_Equivalence_Chart
| Characteristic | Predicate device: SNAP
testing device (K944524) | Modified device:
"Oxi-SNAP" | Palco (K943842) | Mesam IV
(K901466) |
|--------------------------------|-----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Labeling: | (Original submission) | The User's manual
has been updated
to include a
description of
the oximetry
device | Oximetry diagnostics | Apnea &
Snoring
Diagnostics |
| Intended Use: | Recording and analysis
of snoring and apnea | Recording and
analysis of
snoring and apnea | Recording & Analysis
of oximetry | Recording and
analysis of
snoring & apnea |
| Physical Charac-
teristics: | | | | |
| Recording device: | Sony TDC-D7 DAT digital
audio tape recorder | Sony TDC-D7 DAT
digital audio
tape recorder | Oximeter | Recorder (solid
state) |
| Channels acquired: | One: snoring sounds
recorded by microphone | Two: snoring
sounds on one
channel,
Oximetry level on
the other channel | Oximetry and pulse
rate | Snoring
Oxygen Satur-
ation
Body Position
Event Marking
Heart rate |
| User equipment: | DAT recorder, tape,
cannula, microphone | DAT recorder, tape,
cannula, mic-
rophone, and
Oximéter, Palco
Model 305 | Oximeter
Finger Probe | Recorder
Sensors |
| Energy Source: | 120 V 60-wall mount
AC-DC converter 12W
(recommended) or
batteries | 120 V 60-wall
mount AC-DC con-
verter 12W (rec-
ommended) or
batteries Plus | Battery or 120V
60 V wall mount | Battery |
| | | | | |
| Anatomical Sites: | Upper lip | NiCad rechargeable
batteries for the
oximeter (12 hour
life per charge)
Charger is UL list | Finger probe | Finger probe
- Microphone
attached to
patient neck - Chest sensors
for body posit-
ion and EKG. |
| Performance
Testing | Original
submission | Summarized above | Clinical
Evaluation | Unknown to us |
| Safety
Characteristics: | ETL Listed | ETL Listed | CSA - tested
for UL 544 | Unknown to us |
| Electrical
Safety: | Per applicable sections
of 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 15
Class A | Yes, EN55011B
Group
EN60601-1-2 | Unknown to us |
| Oximetry | Not included | Included | Included | Included |
| Intended Popula-
tion | Older than 3 yrs. old | Adults and pediat-
rics | Adults and
pediatrics | Believe that
adults and
pediatrics |
,
3
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
4
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.
5
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
6
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)