Who is the manufacturer of APLAB, MODEL 801D0030?

Sector Medical Corp. filed the 510(k) submission for APLAB, MODEL 801D0030 (K030379).

What is the FDA product code for APLAB, MODEL 801D0030?

MNR. It is classified under 21 CFR 868.2375 as a Class 2 device in the Anesthesiology panel.

What is the regulatory pathway for APLAB, MODEL 801D0030?

510(k) clearance (submission type: Traditional).

What are the predicate devices for APLAB, MODEL 801D0030?

SensorMedics SomnoStar α Series Sleep System (K012085); Biomec SleepFlow (K020607).

Who can help prepare an FDA 510(k) submission like APLAB, MODEL 801D0030?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

APLAB, MODEL 801D0030

K030379 · Sector Medical Corp. · MNR · Aug 29, 2003 · Anesthesiology

Device Facts

Record ID	K030379
Device Name	APLAB, MODEL 801D0030
Applicant	Sector Medical Corp.
Product Code	MNR · Anesthesiology
Decision Date	Aug 29, 2003
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.2375
Device Class	Class 2
Attributes	Pediatric

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.

Device Story

ApLab is a reusable, beeper-sized respiratory pressure sensor system; used at home by patients during sleep. Device inputs: respiratory nasal pressure via disposable, lightweight plastic nasal cannula. Principle of operation: solid-state pressure sensor converts pressure changes to electrical signal levels; proprietary electronic circuitry and embedded software record data. Post-study, device returned for data analysis and report generation. Healthcare providers use output to screen for obstructive sleep apnea syndrome and determine need for formal polysomnography. Benefits: convenient home-based screening; aids clinical decision-making regarding further diagnostic evaluation.

Clinical Evidence

Clinical study compared ApLab and autoscored SomnoStar α PSG against manually scored SomnoStar α PSG (n=9 patients, 4.46 hours average wear time). ApLab sensitivity for apnea/hypopnea events was 69% (PPV 65%); autoscored PSG sensitivity was 21% (PPV 58%). For OSAS detection (AHI threshold 10), ApLab achieved 89% sensitivity and 100% PPV. No device-related adverse effects or abnormal vital signs reported.

Technological Characteristics

Single-channel respiratory pressure monitor; solid-state pressure sensor; 3-Volt Lithium battery power; plastic nasal cannula with hydrophobic 0.2-micron filter; embedded software for data recording; reusable housing with disposable patient interface.

Indications for Use

Indicated for patients 2 years or older to record respiratory nasal pressure during sleep as a screening tool to determine the need for clinical diagnosis and evaluation of obstructive sleep apnea syndrome via polysomnography.

Regulatory Classification

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.

Predicate Devices

SensorMedics SomnoStar α Series Sleep System (K012085)
Biomec SleepFlow (K020607)

Related Devices

K040576 — MICROMESAM BASIC-SET · Map Medizintechnik Fur Arzt Und Patient GmbH · Jul 1, 2004
K061405 — APNEALINK, MODEL 22302 · Resmed Germany, Inc. · Jul 25, 2006
K022294 — APNEACHECK · Im Systems · Apr 25, 2003
K143272 — ApneaLink Air · Resmed Germany, Inc. · Apr 30, 2015
K112822 — SLEEPSTRIP II · S.L.P. , Ltd. · Dec 27, 2011

Submission Summary (Full Text)

{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