(162 days)
Not Found
No
The document describes standard ECG analysis software and mentions compliance with relevant standards for cardiac rhythm and ST-segment measurement algorithms, but does not mention AI or ML.
No.
The device is described as an analyzer and a screening device, not a treatment device. It analyzes recordings, detects arrhythmias, and helps determine the need for clinical diagnosis, but it does not directly provide therapy.
Yes
Explanation: The "Intended Use/Indications for Use" section explicitly states that the device is "intended to be used to analyze recordings of ambulatory electrocardiograms" and is "capable of detecting certain abnormal arrhythmias." It further mentions that the results are for "physician use" to "determine the need for clinical diagnosis and evaluation" and "within their diagnosis of patients," all of which point to a diagnostic function.
Yes
The device description explicitly states "Spacelabs Pathfinder SL Holter Analyzer (Pathfinder SL) is a software-only ECG analysis system". While it interacts with hardware (Holter recorders and a PC), the device itself, as described, is solely the software component.
Based on the provided text, the Spacelabs Pathfinder SL Holter Analyzer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Spacelabs Pathfinder SL Holter Analyzer analyzes electrocardiogram (ECG) recordings, which are electrical signals measured from the surface of the body. It does not analyze biological samples taken from the body.
- Intended Use: The intended use clearly states it analyzes "recordings of ambulatory electrocardiograms" and is used as a "screening device" based on the patient's ECG score.
Therefore, while it is a medical device used for diagnosis and evaluation, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spacelabs Pathfinder SL Holter Analyzer is intended to be used to analyze recordings of ambulatory electrocardiograms made on compatible Holter recorders. It is capable of detecting certain abnormal arrhythmias, and allows the operator to view and edit the ECG and the analysis results, and construct 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 of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature.
Product codes
DOK, DQK, MNR
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 ECG 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.
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
Adult patients only
Intended User / Care Setting
Operator trained in electrocardiography. A qualified medical practitioner should make any diagnosis. ECG recording may be obtained at any location specified by a physician including home, hospital or clinic.
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)
Performance Testing: The Pathfinder SL was tested for performance in accordance with internal requirements and the applicable portions of the following Standards:
- IEC 60601-2-47: 2001, Medical electrical equipment - Particular requirements for the safety including essential performance, of ambulatory electrocardiographic systems;
- ANSI/AAMI EC57: 1998, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms; and
- ANSI/AAMI EC38: 1998, Ambulatory electrocardiographs
Test results indicated that the Pathfinder SL complies with its predetermined specification and with the applicable Standards.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Road | |
| Hertford, SG13 7NW United Kingdom | |
| Submitter Contact: | Mr. Roger Moldon |
| Quality Manager | |
| Spacelabs Healthcare Ltd. | |
| 1 Harforde Court, John Tate Road | |
| Hertford, SG13 7NW United Kingdom | |
| +011 (44) 1992-507730 | |
| roger.moldon@spacelabs.com | |
| Official Contact: | Thomas Kroenke |
| Principal Consultant | |
| Speed To Market, Inc. | |
| PO Box 3018 | |
| Nederland, CO 80466 USA | |
| tkroenke@speedtomarket.net | |
| 303 956 4232 | |
| Manufacturing Site: | Spacelabs Healthcare |
| 5150 220th Avenue SE | |
| Issaquah, WA 98029 | |
| Trade Name: | Spacelabs Model 90217A Ambulatory Blood Pressure (ABP) Monitor |
| Common Name: | Computer, Diagnostic, Programmable |
| Classification Name: | Holter Analyzer |
| Classification | |
| Regulation: | 21 CFR §870.1425 |
| Product Code: | DOK |
:
:
1
510(k) Premarket Notification Spacelabs Healthcare Spacelabs Pathfinder SL Holter Analyzer 510(k) Summary
| Substantially
Equivalent Devices: | New Spacelabs Model | Predicate
510(k) Number | Predicate
Manufacturer / Model |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------------------------------------------------------------------------------|
| | Spacelabs Pathfinder SL
Holter Analyzer | K993620 | Spacelabs (Del Mar
Medical Systems)
Impresario™ Ambulatory
ECG (Holter) Arrhythmia
Analysis Software |
| | | K951902 | Spacelabs (Reynolds
Medical Ltd) Pathfinder
700 Holter Analyzer |
| | | K042745 | Spacelabs (Del Mar
Reynolds Medical, Inc.)
Lifescreen Apnea |
| 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. | | |
KII0001 Page 2 of 4
2
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 to
analyze recordings of ambulatory electrocardiograms made on compatible
Holter recorders. It is capable of detecting certain abnormal arrhythmias, and
allows the operator to view and edit the ECG and the analysis results, and
construct 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. | | | | | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Technology
Comparison: | The Pathfinder SL employs the same technological characteristics as the
predicate device. | | | | | |
| Summary of Performance Testing: | | | | | | |
| Biocompatibility | The Pathfinder SL is software only and does not directly or indirectly contact
the patient. Therefore, biocompatibility testing is not necessary for the
Pathfinder SL. | | | | | |
| Electrical Safety | The Pathfinder SL is software only. Therefore, electrical safety testing is not
necessary for the Pathfinder SL. | | | | | |
| Electromagnetic
Compatibility (EMC)
Testing | The Pathfinder SL is software only. Therefore, EMC testing is not necessary
for the Pathfinder SL. | | | | | |
| Performance Testing | The Pathfinder SL was tested for performance in accordance with internal
requirements and the applicable portions of the following Standards: | | | | | |
| | • IEC 60601-2-47: 2001, Medical electrical equipment - Particular
requirements for the safety including essential performance, of
ambulatory electrocardiographic systems; | | | | | |
| | • ANSI/AAMI EC57: 1998, Testing and reporting performance results of
cardiac rhythm and ST-segment measurement algorithms; and | | | | | |
| | • ANSI/AAMI EC38: 1998, Ambulatory electrocardiographs | | | | | |
| | Test results indicated that the Pathfinder SL complies with its predetermined
specification and with the applicable Standards. | | | | | |
KINDOOV Page 3 of 4
3
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.
4
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.
5
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
6
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 be |
| used to analyze recordings of ambulatory electrocardiograms | |
| made on compatible Holter recorders. It is capable of detecting | |
| certain abnormal arrhythmias, and allows the operator to view | |
| and edit the ECG and the analysis results, and construct 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. |
X_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
1
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________