(29 days)
The Spacelabs Smart Disclosure System, Model 92810 is indicated for use in clinical situations where there is a need for review of physiological waveform information and alarm events up to 72 hours after the fact. Smart Disclosure is also indicated in those situations where a retrospective analysis of monitoring patients' ECG waveform data, that can be annotated and edited, is desired.
The intended use of the Spacelabs Smart Disclosure is to interface with the Spacelabs monitoring network, providing the user with a means of recalling waveform information and performing retrospective analysis. The most recent 72 hours of monitored patient ECG waveform data can be analyzed, with each analysis limited to 24 hours or less.
The Spacelabs Healthcare (Spacelabs) Smart Disclosure System (Smart Disclosure), Model 92810, is a software only medical device that resides on a server or a client workstation. It is an update to the predicate device, the Spacelabs Full Disclosure, Model 91810, cleared by FDA in 510(k) submission K063490. Smart Disclosure is presented as an icon that, when selected, opens Smart Disclosure on a client workstation.
Smart Disclosure allows the recall and retrospective review of up to 72 hours of electrocardiogram (ECG) and other physiological waveforms and alarm events that are stored in the Spacelabs Network Database. The clinician can review vital signs information which enhances the ability to evaluate a patient's history. Smart Disclosure is able to reproduce the waveform data and events on the client workstation graphic display as well as in printed reports. The clinician can review infrequent events and ensures that onsets and terminations of the events are captured, and make standard-sized tracings using a network-connected laser printer. Additionally, the clinician can perform a shape-based retrospective analysis of the ECG waveform data using the Smart Disclosure shape-based retrospective algorithm.
The information provided in the 510(k) summary for the Spacelabs Smart Disclosure System, Model 92810 (K110779) indicates that its premarket notification is based on demonstrating substantial equivalence to a predicate device (Spacelabs Medical Inc. / Full Disclosure System, Model 91810, K063490).
Here's an analysis of the provided text in relation to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state specific, quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) in a table format for a clinical performance study. Instead, it relies on a general statement of compliance with internal requirements and established software development and validation standards.
| Acceptance Criteria (Stated Generally) | Reported Device Performance |
|---|---|
| Compliance with predetermined specifications | "Test results indicated that the Smart Disclosure complies with its predetermined specification and with the applicable Standards." |
| Performance in accordance with internal requirements | "The Smart Disclosure was tested for performance in accordance with internal requirements." |
| Compliance with FDA Software Guidance documents | Implied by adherence to various FDA guidance documents for software in medical devices. |
| Safety and effectiveness | "The results of these activities demonstrate that the Smart Disclosure is safe and effective when used in accordance with its intended use and labeling." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The summary focuses on software validation and verification rather than clinical performance testing with a specific test set of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. As there's no mention of a clinical performance study involving a test set with ground truth established by experts, this detail is absent.
4. Adjudication Method
This information is not provided. Without a clinical performance study and expert-established ground truth, an adjudication method is not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the summary. The submission is a software update and emphasizes technological equivalence and software validation, not a comparison of human reader performance with and without AI assistance.
6. Standalone Performance Study
A standalone performance study (algorithm only, without human-in-the-loop performance) is not explicitly described in terms of specific performance metrics against a defined ground truth. The "retrospective analysis of the ECG waveform data using the Smart Disclosure shape-based retrospective algorithm" is mentioned as a feature, but its standalone performance against quantifiable metrics and ground truth is not detailed. The "performance testing" referenced is primarily software-centric, focused on internal requirements and specifications.
7. Type of Ground Truth Used
The document does not specify a type of ground truth (e.g., expert consensus, pathology, outcomes data) as it primarily describes software validation and verification. If the "shape-based retrospective algorithm" was evaluated, the ground truth for that specific algorithm's performance is not detailed.
8. Sample Size for the Training Set
This information is not provided. The summary does not discuss machine learning model training or a specific training set. The device is described as a "software only medical device" that performs recall, review, and retrospective analysis of existing data, rather than a system that learns from a training set in the typical machine learning sense.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as there is no mention of a training set or machine learning components in the typical sense for which ground truth would be established.
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K110779
510(k) Premarket Notification Spacelabs Healthcare Spacelabs Smart Disclosure System, Model 92810 510(k) Summary
APR 1 9 2011
| Submission Date: | 14 March 2011 | ||
|---|---|---|---|
| Submitter: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029 | ||
| Submitter Contact: | Mr. David J. GeraghtyManager, Regulatory & Quality+1 (425) 657-7200david.geraghty@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 Smart Disclosure System, Model 92810 | ||
| Common Name: | Computer, Diagnostic, Programmable | ||
| Classification Name: | Programmable Diagnostic Computer | ||
| ClassificationRegulation: | 21 CFR §870.1425 | ||
| Product Code: | DQK | ||
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate 510(k) Number | Predicate Manufacturer / Model |
| Spacelabs Smart DisclosureSystem, Model 92810 | K063490 | Spacelabs Medical Inc. /Full Disclosure System,Model 91810 |
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K川0779
510(k) Premarket Notification Spacelabs Healthcare Spacelabs Smart Disclosure System, Model 92810 510(k) Summary
| Device Description: | The Spacelabs Healthcare (Spacelabs) Smart Disclosure System (SmartDisclosure), Model 92810, is a software only medical device thatresides on a server or a client workstation. It is an update to thepredicate device, the Spacelabs Full Disclosure, Model 91810, clearedby FDA in 510(k) submission K063490. Smart Disclosure is presentedas an icon that, when selected, opens Smart Disclosure on a clientworkstation.Smart Disclosure allows the recall and retrospective review of up to 72hours of electrocardiogram (ECG) and other physiological waveformsand alarm events that are stored in the Spacelabs Network Database.The clinician can review vital signs information which enhances theability to evaluate a patient's history. Smart Disclosure is able toreproduce the waveform data and events on the client workstationgraphic display as well as in printed reports. The clinician can reviewinfrequent events and ensures that onsets and terminations of the eventsare captured, and make standard-sized tracings using a network-connected laser printer. Additionally, the clinician can perform a shape-based retrospective analysis of the ECG waveform data using the SmartDisclosure shape-based retrospective algorithm. |
|---|---|
| Intended Use: | The Spacelabs Smart Disclosure System, Model 92810 is indicated foruse in clinical situations where there is a need for review ofphysiological waveform information and alarm events up to 72 hoursafter the fact. Smart Disclosure is also indicated in those situationswhere a retrospective analysis of monitoring patients' ECG waveformdata, that can be annotated and edited, is desired.The intended use of the Spacelabs Smart Disclosure is to interface withthe Spacelabs monitoring network, providing the user with a means ofrecalling waveform information and performing retrospective analysis.The most recent 72 hours of monitored patient ECG waveform data canbe analyzed, with each analysis limited to 24 hours or less. |
| TechnologyComparison: | The Smart Disclosure employs the same technological characteristics as thepredicate device. |
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KII0779
510(k) Premarket Notification Spacelabs Healthcare Spacelabs Smart Disclosure System, Model 92810 510(k) Summary
Summary of Performance Testing:
| Performance Testing | The Smart Disclosure was tested for performance in accordance with internalrequirements. |
|---|---|
| Test results indicated that the Smart Disclosure complies with itspredetermined specification and with the applicable Standards. | |
| Software Testing | Software device modifications made to the Smart Disclosure were designedand developed according to a robust software development process, and wererigorously verified and validated. |
| Software information is provided in accordance with: | |
| • FDA guidance: The content of premarket submissions for softwarecontained 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 guidancefor industry and FDA staff, 11 Jan 02. | |
| Test results indicate that the Smart Disclosure complies with its predeterminedspecification. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the software device modificationsmade to the Smart Disclosure. The results of these activities demonstrate thatthe Smart Disclosure is safe and effective when used in accordance with itsintended use and labeling. |
| Therefore, the Smart Disclosure is considered substantially equivalent to thepredicate device. |
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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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spacelabs Helathcare c/o Mr. Thomas Kroenke Speed to Market, Inc. PO Box 3018 Nederland, CO 80466
APR 1 9 2011
Re: K110779
Trade Name: Spacelabs Smart Disclosure System, Model 92810 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: March 14, 2011 Received: March 21, 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 misburanding 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.D. 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): | K 110779 |
|---|---|
| Device Name: | Spacelabs Smart Disclosure System, Model 92810 |
| Indications for Use: | The Spacelabs Smart Disclosure System, Model 92810 isindicated for use in clinical situations where there is a need forreview of physiological waveform information and alarm eventsup to 72 hours after the fact. Smart Disclosure is also indicatedin those situations where a retrospective analysis of monitoringpatients' ECG waveform data, that can be annotated and edited,is desired.The intended use of the Spacelabs Smart Disclosure is tointerface with the Spacelabs monitoring network, providing theuser with a means of recalling waveform information andperforming retrospective analysis. The most recent 72 hours ofmonitored patient ECG waveform data can be analyzed, witheach analysis limited to 24 hours or less. |
X ____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(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 K110779
§ 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).