(156 days)
Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is receiled to sinus rhythm in nature.
Holter LX Analysis is a software option to the Holter for Windows software (K930564). The software has been designed to detect sleep disordered breathing due to obstructive apneas or hyponneas. The software uses 2 channel ECG and oximetry data collected via the DR180+ Holter Recorder to calculate the patient's Apnea-Hypopnea Index (AHI). The Holter and Oxymetry ECG data obtained by monitoring is not analyzed at the time of recording is complete, the data must be downloaded to a compatible NorthEast Monitoring Holter LX Analysis with sleep apnea software system to be analyzed by a healthcare professional. The sleep apnea monitoring algorithm used in the subject device is the exact algorithm already cleared by FDA. The Sleep Technician or Physician will utilize standard Holter procedure to hook up the recorder to the patient. The patient will sleep with the recorder for one night in order to collect data. Either the patient or a sleep clinician will note the time that the patient falls asleep and awakens. The sampling rate is 180 samples/second. The Holter LX Analysis software detects each R-wave. The calculations of AHI are performed. The Holter LX Analysis software can only be used in conjunction with North East Monitoring Holter recorders.
Here's an analysis of the provided text regarding the Holter LX Analysis device, focusing on its acceptance criteria and the study used for validation:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria (e.g., minimum sensitivity, specificity) for the Holter LX Analysis software. Instead, it relies on demonstrating substantial equivalence to a predicate device.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Sensitivity | Substantially equivalent to predicate device (LifeScreen Apnea) | Equivalent results to predicate device |
| Specificity | Substantially equivalent to predicate device (LifeScreen Apnea) | Equivalent results to predicate device |
| Accuracy | Substantially equivalent to predicate device (LifeScreen Apnea) | Equivalent results to predicate device |
| Positive Predictivity | Substantially equivalent to predicate device (LifeScreen Apnea) | Equivalent results to predicate device |
Explanation: The filing states, "Comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device found equivalent results for sensitivity, specificity, accuracy, and positive predictivity. We believe the subject device is substantially equivalent to the predicate device." This implies that the acceptance criteria were met by showing performance equivalent to the predicate, K042745 (LifeScreen Apnea).
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the comparative test set.
- Sample Size: Not specified.
- Data Provenance: The text states, "The underlying algorithm remains the same, but the AHI is calculated using oximetry data from a study conducted by Biancamed." This suggests the test data (or at least the oximetry data used for AHI calculation) came from a prospective or retrospective study conducted by Biancamed. The country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given that the algorithm itself is the exact same as the predicate and the study focuses on the incorporation of oximetry, it's possible the original predicate study established a ground truth against which the algorithm was initially validated, and this submission leverages that, with a focus on verifying the oximetry data integration.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this submission. The study described is a comparison of the new device's computational output (Holter LX Analysis with oximetry) to a predicate device's computational output (LifeScreen Apnea, which used the same base algorithm). There is no mention of human readers.
6. Standalone Performance Study
Yes, a standalone (algorithm only) performance study was implicitly done. The "comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device" constitutes a standalone performance comparison between two algorithms (one with an oximetry enhancement). However, it's a comparison between algorithms, not against an independent "gold standard" in this specific submission. The original validation of the algorithm (when used in LifeScreen Apnea) would have been the standalone validation.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for the comparison study or the original algorithm validation. However, as it is a device to determine the "need for clinical diagnosis and evaluation by polysomnography," it is highly probable that the original algorithm's ground truth was established by polysomnography (PSG), which is the gold standard for sleep disorder diagnosis. The current submission focuses on equating results with the predicate device, not re-validating against the ultimate clinical ground truth itself.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It mentions the algorithm is "the exact algorithm already cleared by FDA" and sourced from Biancamed. This implies the training (if any was needed for the base algorithm) occurred prior to its use in the predicate device. For the oximetry enhancement, it's unclear if new training was involved or if it was a direct application of existing scientific principles.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for the training set was established. Similar to the test set, it's highly probable that the original algorithm (developed by Biancamed) was trained and validated against polysomnography (PSG) as the ultimate ground truth for sleep apnea events. This submission focuses on the application of that already cleared algorithm, with the added oximetry data.
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K081861 Page 1 of 3
DEC 0 4 2008
510(k) Summary
Date Prepared [21 CFR 807.92(a)(1)]
June 23, 2008 [Updated 12/3/08]
Submitter's Information [21 CFR 807.92(a)(1)}
Joseph M. Azary C/o NorthEast Monitoring Inc. 543 Long Hill Avenue Shelton, CT. 06484
Orchid Design has received authorization to submit this 510(k) on behalf of the sponsor NorthEast Monitoring Inc.
Manufacturer / Sponsor Information:
NorthEast Monitoring Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 Contact: Sherry Strickland (Regulatory / Office Manager) Contact Tel: (978)461-3992 Contact Fax: (978) 461-5991 Email: sstrickland@nemon.com
FDA-registered medical device under establishment# 1224919.
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Device Trade Or Proprietary Names
The device trade names are:
- � Holter LX Analysis
Device Common, Usual, or Classification Names
Common/Usual Names: Sleep Apnea Analysis Software Classification Name: Ventilatory Effort Recorder
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Classification
Class II, 21 CFR 868.2375, MNR Class II, 21 CFR 870.2800, DSH
Predicate Device [21 CFR 807.92(a)(3)]
- . LifeScreen Apnea (K042745)
- . NorthEast Monitoring DR-180+ Oxy Holter (K004007)
- . Holter for Windows (K930564)
The device is an option for the Holter software, which was cleared under K930564.
The Holter monitors used with the Holter for Windows software have been cleared under K061293, K041901, and K004007.
The DR-180+ Oxy Holter is a Holter Monitor that can also detect oxygen saturation in blood (SpO2). The DR-180+ Oxy Holter is utilized with the Holter LX Analysis software subject to this submission.
K081861 Page 2023
The subject device (Holter LX Analysis software) utilizes the exact algorithm as the predicate device (LifeScreen Apnea). The algorithm is provided to both manufacturers by Biancamed.
The main differences are as follows:
- The Holter LX Analysis can also utilize oxygen saturation in blood (SPO2) when used with ◆ the DR180+ Oxy Holter.
- . The underlying algorithm remains the same, but the AHI is calculated using oximetry data from a study conducted by Biancamed.
- The Holter LX Analysis is used with North East Monitoring Holter Monitors. ●
Comparison of test data between the Holter LX Analysis software and the LifeScreeen Apnea device found equivalent results for sensitivity, specificity, accuracy, and positive predictivity. We believe the subject device is substantially equivalent to the predicate device.
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K081861 Page 3 of 3
Description of the Device [21 CFR 807.92(a)(4)]
Holter LX Analysis is a software option to the Holter for Windows software (K930564).
The software has been designed to detect sleep disordered breathing due to obstructive apneas or hyponneas. The software uses 2 channel ECG and oximetry data collected via the DR180+ Holter Recorder to calculate the patient's Apnea-Hypopnea Index (AHI). The Holter and Oxymetry ECG data obtained by monitoring is not analyzed at the time of recording is complete, the data must be downloaded to a compatible NorthEast Monitoring Holter LX Analysis with sleep apnea software system to be analyzed by a healthcare professional.
The sleep apnea monitoring algorithm used in the subject device is the exact algorithm already cleared by FDA.
The Sleep Technician or Physician will utilize standard Holter procedure to hook up the recorder to the patient. The patient will sleep with the recorder for one night in order to collect data. Either the patient or a sleep clinician will note the time that the patient falls asleep and awakens. The sampling rate is 180 samples/second.
The Holter LX Analysis software detects each R-wave. The calculations of AHI are performed. The Holter LX Analysis software can only be used in conjunction with North East Monitoring Holter recorders.
The Holter software was originally cleared by FDA under K930564. The software subject to this 510(k) adds the sleep apnea monitoring capabilities.
The North East Monitoring DR180+ Oxy was cleared under K004007. There are no hardware as a result of this addition.
Intended Use [21 CFR 807.92(a)(5)]
Indications For Use: Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours during which the ECG is predominantly sinus rhythm in nature.
Technological Characteristics [21 CFR 807.92(a)(6)]
NorthEast Monitoring, Inc. believes that the subject device is substantially equivalent to the predicate device.
Performance Data [21 CFR 807.92(b)(1)]
The subject device has been subjected to software validation and comparison studies.
Conclusion [21 CFR 807.92(b)(3)]
We believe the changes are minor and conclude that the subject device is as safe and effective as the predicate devices
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is written in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NorthEast Monitoring Incorporated C/O Mr. Joseph M. Azary Senior Regulatory Consultant Orchid Design Orthopedic Solutions 80 Shelton Technology Center Shelton, Connecticut 06484
Re: K081861
DEC 0 4 2008
Trade/Device Name: Holter LX Analysis Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: II Product Code: MNR Dated: November 12, 2008 Received: November 17, 2008
Dear Mr. Azary:
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.
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Page 2 - Mr. Azary
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sudette Y. Michien Oms.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):_ K08) 86
Device Name: NorthEast Monitoring Inc. Holter LX Analysis
Indications For Use: Intended for use on adult patients only as a screening device to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient's score. The ECG recording may be obtained at any location specified by a physician including home, hospital, or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is receiled to sinus rhythm in nature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Luan M. Zir
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: KD81861
Page 1 of 1
§ 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).