(205 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the device and performance studies focuses on traditional signal processing and comparison to existing scoring methods.
No.
The device is intended for screening and diagnostic purposes, not for treating a condition.
Yes
The device description states, "This physician prescribed device will provide a screening index for and aid in the diagnosis of obstructive sleep apnea syndrome." This explicitly indicates a diagnostic purpose.
No
The device description explicitly states that the ApLab contains "proprietary electronic circuitry and embedded software" and is a "re-usable, respiratory pressure sensor system," indicating it includes hardware components beyond just software.
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 intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of potential donors and recipients, or to monitor therapeutic measures.
- ApLab's Function: The ApLab records respiratory nasal pressure during sleep. It does not examine specimens derived from the human body in vitro. It is a device that directly measures a physiological parameter (respiratory pressure) from the patient.
- Intended Use: The intended use is to record respiratory nasal pressure and provide a screening index for obstructive sleep apnea syndrome. This is a direct physiological measurement and analysis, not an in vitro examination of a specimen.
Therefore, the ApLab falls under the category of a medical device that performs a physiological measurement, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
Product codes
MNR
Device Description
The ApLab is a re-usable, respiratory pressure sensor system intended to provide a recording of respiratory pressure during sleep. This physician prescribed device will provide a screening index for and aid in the diagnosis of obstructive sleep apnea syndrome. The device is about the size of a common beeper that contains proprietary electronic circuitry and embedded software. The ApLab utilizes a disposable, lightweight plastic nasal cannula that can be conveniently worn while sleeping at home. At completion of a sleep study the device is returned for data analysis and report generation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
2 yrs or older
Intended User / Care Setting
Not Found
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
Clinical tests: In Clinical tests, ApLab automatic scoring and SomnoStar a autoscore PSG were compared to a manually scored SomnoStar α PSG. Breath by breath accuracy was verified manually on both systems.
The efficacy results are:
- The ApLab and PSG were equivalent in mean AHI.
- The ApLab sensitivity was 69% with a PPV of 65% on an apnea and hypopnea event count when compared to a manually scored PSG.
- The autoscored PSG sensitivity was 21% with a PPV of 58% on an apnea and hypopnea event count when compared to a manually scored PSG.
- The ApLab and autoscored PSG were statistically equivalent on PPV and the ApLab was statistically superior on sensitivity.
- When compared to an industry standard AHI of 10, the ApLab produced a sensitivity of 89% with a PPV of 100% when compared to a manually scored PSG to determine if a patient has OSAS.
- The ApLab and PSG are equivalent on a breath-by-breath basis at all three time intervals.
- The ApLab provides a complete record of breathing to confirm the AHI scoring.
The safety results are: - Nine patients wore the ApLab for an average of 4.46 hours with no device related adverse effects. There were no abnormal vital signs related to the ApLab. There were no early terminations.
Conclusion: The performance tests and clinical trials completed on the ApLab demonstrate substantial equivalence to the predicate devices. The safety and effectiveness is demonstrated by the tests confirming accuracy of the recorded data to the product specifications and comparison to the predicate device clinical trial results.
Key Metrics
Sensitivity, PPV
Predicate Device(s)
SensorMedics SomnoStar α Series Sleep System K012085, Biomec SleepFlow K020607
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo for Sector Medical Corp, along with the date AUG 2 9 2003. The logo consists of a stylized "S" shape on the left, followed by the word "SECTOR" in bold, uppercase letters. Below "SECTOR" is the text "Medical Corp" in a smaller font size. The date is positioned above the logo.
320 Northpoint Parkway Suite P Acworth, Georgia 30102
Phone: 770.975.1384 Fax: 770.975.1385
510(k) SUMMARY
| The assigned
510(k) number is: | K030379 | |
---|---|---|
Prepared By: | Sector Medical Corp. | |
320 Northpoint Parkway, Suite P | ||
Acworth, GA 30102 | ||
Telephone: | ||
Fax: | 770.975.1384 | |
770.975.1385 | ||
Contact: | Bradley Jeffries, MD, MS | |
Date prepared: | August 28, 2003 | |
Proprietary name: | ||
Classification name: | ||
Common name: | ApLab™ | |
Ventilatory Effort Recorder | ||
Airflow Pressure Sensor | ||
Classification: | ||
Regulation number: | ||
Product code: | Class II | |
868.2375 | ||
MNR | ||
Predicate device(s): | SensorMedics SomnoStar α Series Sleep System | |
510(k) Number: K012085 |
Biomec SleepFlow
510(k) Number: K020607 | |
Description of device:
The ApLab is a re-usable, respiratory pressure sensor system intended to provide a recording of respiratory pressure during sleep. This physician prescribed device will provide a screening index for and aid in the diagnosis of obstructive sleep apnea syndrome. The device is about the size of a common beeper that contains proprietary electronic circuitry and embedded software. The ApLab utilizes a disposable, lightweight plastic nasal cannula that can be conveniently worn while sleeping at home. At completion of a sleep study the device is returned for data analysis and report generation.
Intended use:
ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
1
Technological Characteristics:
The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. This is to demonstrate that ApLab has no significant differences from the predicate device that would adversely affect product safety and effectiveness.
| Comparison
Parameter | SensorMedics
SomnoStar α Series
Sleep System K012085 | Biomec SleepFlow
K020607 | Sector Medical
Corp
ApLab |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Intended Use | Recording physiological
parameters during sleep,
including respiratory flow
and effort, EEG,
electroculogram,
electromyogram, ECG,
oxygen saturation, etc. | Recording airflow,
snore, body position,
thoracic effort,
abdominal effort and
body position during
sleep. | Recording
respiratory nasal
pressure during
sleep. |
| Population | Not specified | 2 yrs or older | 2 yrs or older |
| Power Source | 115 VAC | 3-Volt (2AA in series) | 3-Volt Lithium battery |
| Number of
Channels | Variable with a nominal
channel count of 14 | Four channels | Single channel |
| Method of
Connection to
the Patient | Plastic tubing and
cannula for pressure
sensing; elastic cloth
material for effort belts;
insulated electrical
sensors. | Plastic tubing and
cannula for pressure
sensing; elastic cloth
material for effort
belts | Plastic tubing and
cannula for pressure
sensing; elastic cloth
material belt to
support unit. |
| Safety
Characteristics | Uses non-conducting,
disposable, plastic
cannula containing a
hydrophobic 0.2 micron
filter; insulated electrical
connections to ensure
patient isolation. | Use non-conducting,
disposable, plastic
cannula containing a
hydrophobic 0.2
micron filter. | Use non-conducting,
disposable, plastic
cannula containing a
hydrophobic 0.2
micron filter. |
| Re-use | Plastic cannula & filter
are single use
disposable. Remaining
portions require
cleaning. | Plastic cannula &
filter are single use
disposable.
Remaining portions
require cleaning. | Plastic cannula &
filter are single use
disposable.
Remaining portions
require cleaning. |
| Sensor
Technology | Utilizes various sensor
technologies including
solid-state pressure
sensor, Gold cup
electrodes, thermistors,
strain gauges, and
oximetry. | Utilizes solid-state
pressure sensor that
converts pressure
changes to electrical
signal levels. | Utilizes solid-state
pressure sensor that
converts pressure
changes to electrical
signal levels. |
2
Performance Data:
Clinical tests:
In Clinical tests, ApLab automatic scoring and SomnoStar a autoscore PSG were compared to a manually scored SomnoStar α PSG. Breath by breath accuracy was verified manually on both systems.
The efficacy results are:
- The ApLab and PSG were equivalent in mean AHI. .
- The ApLab sensitivity was 69% with a PPV of 65% on an apnea and ● hypopnea event count when compared to a manually scored PSG.
- The autoscored PSG sensitivity was 21% with a PPV of 58% on an apnea . and hypopnea event count when compared to a manually scored PSG.
- The ApLab and autoscored PSG were statistically equivalent on PPV and . the ApLab was statistically superior on sensitivity.
- When compared to an industry standard AHI of 10, the ApLab produced a . sensitivity of 89% with a PPV of 100% when compared to a manually scored PSG to determine if a patient has OSAS.
- The ApLab and PSG are equivalent on a breath-by-breath basis at all three . time intervals.
- The ApLab provides a complete record of breathing to confirm the AHI . scoring.
The safety results are:
- Nine patients wore the ApLab for an average of 4.46 hours with no device . related adverse effects. There were no abnormal vital signs related to the ApLab. There were no early terminations.
Conclusion:
The performance tests and clinical trials completed on the ApLab demonstrate substantial equivalence to the predicate devices. The safety and effectiveness is demonstrated by the tests confirming accuracy of the recorded data to the product specifications and comparison to the predicate device clinical trial results.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 9 2003
Bradley Jeffries MD, MS Vice President Sector Medical Corporation 320 Northpoint Parkway, Suite P Acworth, Georgia 30102
Re: K030379
Trade/Device Name: ApLab Ventilatory Effort Recorder, Model 801D0030 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: June 13, 2003 Received: June 18, 2003
Dear Dr. Jeffries:
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.
4
Page 2 - Dr. Jeffries
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 (OS) 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) 594-4646. 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 yours.
Susan Punner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(K) NUMBER: K030379
Indications For Use Statement
ApLab is intended for use in recording respiratory nasal pressure during sleep. The device is intended for use as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score.
Signature
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental
510(k) Number:
/ Prescription Use