The Spacelabs Pathfinder SL Holter Analyzer is 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 predominantly sinus rhythm in nature.

Device Description

Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-only ECG analysis system for recording and analyzing up to 24 hours of 12 lead EGC or seven days of continuous 3 lead ambulatory ECG. Pathfinder SL is designed to operate on a Microsoft Windows® based personal computer (PC) platform, and contains provisions for networking. Pathfinder SL is compatible with Windows XP, Vista, or Windows 7 32-bit (ensure the latest service packs installed) operating systems.

Pathfinder SL is used in conjunction with Spacelabs Healthcare's Sentinel Cardiology Information Management System (Sentinel), and is sold only for use with Sentinel.

In conjunction with Sentinel, Pathfinder SL can acquire data from Spacelabs Holter recorders, analyze up to 12 channels of ECG data, providing classification, editing, and reporting of arrhythmia, ST segment, heart rate variability and pacer performance, and allows the operator to construct a report for physicians to use within their diagnosis of patients. Pathfinder SL is compatible with Lifecard CF, Lifecard 12, evo and Aria Holter Recorders.

ECG from pre-existing stored analyses created with the previous Spacelabs Healthcare Impresario or Pathfinder Holter analyzer systems can be analyzed from scratch using Pathfinder SL.

Pathfinder SL should be used by an operator trained in electrocardiography. A qualified medical practitioner should make any diagnosis.

AI/ML Overview

Acceptance Criteria and Device Performance Study for Spacelabs Pathfinder SL Holter Analyzer

This analysis is based on the provided 510(k) Premarket Notification summary for the Spacelabs Pathfinder SL Holter Analyzer (K110001).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Standard	Reported Device Performance
Internal requirements	"Test results indicated that the Pathfinder SL complies with its predetermined specification."
IEC 60601-2-47: 2001, Medical electrical equipment - Particular requirements for the safety including essential performance, of ambulatory electrocardiographic systems	"Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing).
ANSI/AAMI EC57: 1998, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms	"Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing).
ANSI/AAMI EC38: 1998, Ambulatory electrocardiographs	"Test results indicated that the Pathfinder SL complies with... the applicable Standards." (Implicitly includes this standard, as it is listed as one of the applicable standards for performance testing).
FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05	"Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance).
FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99	"Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance).
FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02	"Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated... Test results indicate that the Pathfinder SL complies with its predetermined specification." (Implicitly, adherence to FDA guidance is part of the robust development process and compliance).
Safety and effectiveness as per intended use and labeling	"Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Pathfinder SL. The results of these activities demonstrate that the Pathfinder SL is safe and effective when used in accordance with its intended use and labeling." This also forms the basis for the "Substantially Equivalent" determination.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the performance test set.

Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It only mentions "[acquiring] data from Spacelabs Holter recorders."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The 510(k) summary does not specify the number of experts used to establish ground truth for the test set, nor does it detail their qualifications. The device is intended to "allow the operator to view and edit the ECG and the analysis results, and construct a report for physician use," and that "A qualified medical practitioner should make any diagnosis." This implies human review, but the details of ground truth establishment for the test set are not provided.

4. Adjudication Method for the Test Set

The 510(k) summary does not describe the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The 510(k) summary does not mention or provide details of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers improving with or without AI assistance is reported. The device is a "software-only ECG analysis system" used in conjunction with human operators and physicians for diagnosis.

6. Standalone Performance Study

Yes, a standalone performance study was done for the algorithm. The "Performance Testing" section states, "The Pathfinder SL was tested for performance in accordance with internal requirements and the applicable portions of the following Standards," and "Test results indicated that the Pathfinder SL complies with its predetermined specification and with the applicable Standards." This implies testing of the algorithm's performance independent of human-in-the-loop improvements, demonstrating its ability to detect arrhythmias and analyze ECG data.

7. Type of Ground Truth Used

The type of ground truth used for the performance testing is not explicitly stated beyond adherence to internal specifications and external standards (IEC 60601-2-47, ANSI/AAMI EC57, ANSI/AAMI EC38). These standards typically involve databases with expert-annotated arrhythmias or synthesized signals with known characteristics. However, the specific methodology for establishing ground truth as applied to this device's test set is not detailed.

8. Sample Size for the Training Set

The 510(k) summary does not state the sample size for the training set. It primarily focuses on the device's performance against established standards and internal specifications after development.

9. How the Ground Truth for the Training Set Was Established

The 510(k) summary does not describe how the ground truth for the training set was established. As this is a 510(k) submission, the emphasis is on demonstrating substantial equivalence to a predicate device and adherence to recognized standards, rather than the developmental details of a novel algorithm's training process.

Summary

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长110001

JUN 1 4 2011

510(k) Premarket Notification Spacelabs Healthcare Spacelabs Pathfinder SL Holter Analyzer 510(k) Summary

Submission Date:	25 May 2010
Submitter:	Spacelabs Healthcare Ltd.1 Harforde Court, John Tate RoadHertford, SG13 7NW United Kingdom
Submitter Contact:	Mr. Roger MoldonQuality ManagerSpacelabs Healthcare Ltd.1 Harforde Court, John Tate RoadHertford, SG13 7NW United Kingdom+011 (44) 1992-507730roger.moldon@spacelabs.com
Official Contact:	Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029
Trade Name:	Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor
Common Name:	Computer, Diagnostic, Programmable
Classification Name:	Holter Analyzer
ClassificationRegulation:	21 CFR §870.1425
Product Code:	DOK

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510(k) Premarket Notification Spacelabs Healthcare Spacelabs Pathfinder SL Holter Analyzer 510(k) Summary

SubstantiallyEquivalent Devices:	New Spacelabs Model	Predicate510(k) Number	PredicateManufacturer / Model
	Spacelabs Pathfinder SLHolter Analyzer	K993620	Spacelabs (Del MarMedical Systems)Impresario™ AmbulatoryECG (Holter) ArrhythmiaAnalysis Software
		K951902	Spacelabs (ReynoldsMedical Ltd) Pathfinder700 Holter Analyzer
		K042745	Spacelabs (Del MarReynolds Medical, Inc.)Lifescreen Apnea
Device Description:	Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-onlyECG analysis system for recording and analyzing up to 24 hours of 12 leadEGC or seven days of continuous 3 lead ambulatory ECG. Pathfinder SL isdesigned to operate on a Microsoft Windows® based personal computer (PC)platform, and contains provisions for networking. Pathfinder SL is compatiblewith Windows XP, Vista, or Windows 7 32-bit (ensure the latest service packsinstalled) operating systems.
	Pathfinder SL is used in conjunction with Spacelabs Healthcare's SentinelCardiology Information Management System (Sentinel), and is sold only foruse with Sentinel.
	In conjunction with Sentinel, Pathfinder SL can acquire data from SpacelabsHolter recorders, analyze up to 12 channels of ECG data, providingclassification, editing, and reporting of arrhythmia, ST segment,heart rate variability and pacer performance, and allows the operator toconstruct a report for physicians to use within their diagnosis of patients.Pathfinder SL is compatible with Lifecard CF, Lifecard 12, evo and AriaHolter Recorders.
	ECG from pre-existing stored analyses created with the previous SpacelabsHealthcare Impresario or Pathfinder Holter analyzer systems can be analyzedfrom scratch using Pathfinder SL.
	Pathfinder SL should be used by an operator trained in electrocardiography. Aqualified medical practitioner should make any diagnosis.

KII0001 Page 2 of 4

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510(k) Premarket Notification Spacelabs Healthcare Spacelabs Pathfinder SL Holter Analyzer 510(k) Summary

Intended Use:	The Spacelabs Pathfinder SL Holter Analyzer is intended to be used toanalyze recordings of ambulatory electrocardiograms made on compatibleHolter recorders. It is capable of detecting certain abnormal arrhythmias, andallows the operator to view and edit the ECG and the analysis results, andconstruct a report for physician use.The Spacelabs Pathfinder SL Holter Analyzer is 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 ofat least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
TechnologyComparison:	The Pathfinder SL employs the same technological characteristics as thepredicate device.
Summary of Performance Testing:
Biocompatibility	The Pathfinder SL is software only and does not directly or indirectly contactthe patient. Therefore, biocompatibility testing is not necessary for thePathfinder SL.
Electrical Safety	The Pathfinder SL is software only. Therefore, electrical safety testing is notnecessary for the Pathfinder SL.
ElectromagneticCompatibility (EMC)Testing	The Pathfinder SL is software only. Therefore, EMC testing is not necessaryfor the Pathfinder SL.
Performance Testing	The Pathfinder SL was tested for performance in accordance with internalrequirements and the applicable portions of the following Standards:
	• IEC 60601-2-47: 2001, Medical electrical equipment - Particularrequirements for the safety including essential performance, ofambulatory electrocardiographic systems;
	• ANSI/AAMI EC57: 1998, Testing and reporting performance results ofcardiac rhythm and ST-segment measurement algorithms; and
	• ANSI/AAMI EC38: 1998, Ambulatory electrocardiographs
	Test results indicated that the Pathfinder SL complies with its predeterminedspecification and with the applicable Standards.

KINDOOV Page 3 of 4

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510(k) Premarket Notification Spacelabs Healthcare Spacelabs Pathfinder SL Holter Analyzer 510(k) Summary

Software Testing

Software device modifications made to the Pathfinder SL were designed and developed according to a robust software development process, and were rigorously verified and validated.

Software information is provided in accordance with:

. FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05;
. FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; and
. FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.

Test results indicate that the Pathfinder SL complies with its predetermined specification.

Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Pathfinder SL. The results of these activities demonstrate that the Pathfinder SL is safe and effective when used in accordance with its intended use and labeling.

Therefore, the Pathfinder SL is considered substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and flowing design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Spacelabs Healthcare Ltd. c/o Mr. Thomas Kroenke Speed to Market, Inc. PO Box 3018 Nederland, CO 80466

JUN 1 4 2011

Re: K110001

Trade Name: Spacelabs Pathfinder SL Holter Analyzer Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK and MNR Dated: May 28, 2011 Received: June 1, 2011

Dear Mr. Kroenke:

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. Thomas Kroenke

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 (QS) 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bram D. Zuckerman. M. C Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	K110001
Device Name:	Spacelabs Pathfinder SL Holter Analyzer
Indications for Use:	The Spacelabs Pathfinder SL Holter Analyzer is intended to beused to analyze recordings of ambulatory electrocardiogramsmade on compatible Holter recorders. It is capable of detectingcertain abnormal arrhythmias, and allows the operator to viewand edit the ECG and the analysis results, and construct a reportfor physician use.The Spacelabs Pathfinder SL Holter Analyzer is intended for useon adult patients only as a screening device to determine theneed for clinical diagnosis and evaluation by polysomnographybased on the patient's score. The ECG recording may be obtainedat any location specified by a physician including home, hospitalor clinic. Subjects screened for sleep apnea should have periodsof sleep ofat least 4 hours duration during which the ECG ispredominantly sinus rhythm in nature.

510(k) Number (if known):

K110001

Device Name:

Spacelabs Pathfinder SL Holter Analyzer

Indications for Use:

The Spacelabs Pathfinder SL Holter Analyzer is intended to beused to analyze recordings of ambulatory electrocardiogramsmade on compatible Holter recorders. It is capable of detectingcertain abnormal arrhythmias, and allows the operator to viewand edit the ECG and the analysis results, and construct a reportfor physician use.The Spacelabs Pathfinder SL Holter Analyzer is intended for useon adult patients only as a screening device to determine theneed for clinical diagnosis and evaluation by polysomnographybased on the patient's score. The ECG recording may be obtainedat any location specified by a physician including home, hospitalor clinic. Subjects screened for sleep apnea should have periodsof sleep ofat least 4 hours duration during which the ECG ispredominantly sinus rhythm in nature.

X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).