(29 days)
No
The description focuses on retrospective review, recall, and analysis of physiological data using a "shape-based retrospective algorithm," which is not explicitly stated or implied to be AI/ML. There is no mention of learning, training, or adaptive capabilities.
No
The device is described as a software-only medical device that allows for the recall and retrospective review of physiological waveform information and alarm events. It is used for analysis and review, not for directly treating or diagnosing a condition.
No
The device is for reviewing and analyzing physiological waveform data and alarm events retrospectively, not for making an initial diagnosis. It enhances the ability to evaluate a patient's history.
Yes
The device description explicitly states, "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."
Based on the provided information, the Spacelabs Smart Disclosure System, Model 92810 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Smart Disclosure Function: The Smart Disclosure System's intended use and description clearly state that it is for the review and analysis of physiological waveform information and alarm events collected from patients via a monitoring network. It processes data that has already been acquired from the patient, not specimens taken from the patient.
- No Specimen Handling: There is no mention of the device handling, preparing, or analyzing biological specimens.
Therefore, the Spacelabs Smart Disclosure System falls under the category of a medical device that processes and displays physiological data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DQK
Device Description
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.
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
Not Found
Intended User / Care Setting
Not Found
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: Performance Testing, Software Testing
Sample Size: Not Found
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results: Test results indicated that the Smart Disclosure complies with its predetermined specification and with the applicable Standards. Test results indicate that the Smart Disclosure complies with its predetermined specification. Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the Smart Disclosure. The results of these activities demonstrate that the Smart Disclosure is safe and effective when used in accordance with its intended use and labeling.
Key Metrics
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
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 Healthcare | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 | |||
| Submitter Contact: | Mr. David J. Geraghty | ||
| Manager, Regulatory & Quality | |||
| +1 (425) 657-7200 | |||
| david.geraghty@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 Smart Disclosure System, Model 92810 | ||
| Common Name: | Computer, Diagnostic, Programmable | ||
| Classification Name: | Programmable Diagnostic Computer | ||
| Classification | |||
| Regulation: | 21 CFR §870.1425 | ||
| Product Code: | DQK | ||
| Substantially | |||
| Equivalent Devices: | New Spacelabs Model | Predicate 510(k) Number | Predicate Manufacturer / Model |
| Spacelabs Smart Disclosure | |||
| System, Model 92810 | K063490 | Spacelabs Medical Inc. / | |
| Full Disclosure System, | |||
| Model 91810 |
1
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 (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. |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | 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. |
| Technology
Comparison: | The Smart Disclosure employs the same technological characteristics as the
predicate device. |
2
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 internal
requirements. |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test results indicated that the Smart Disclosure complies with its
predetermined specification and with the applicable Standards. |
| Software Testing | Software device modifications made to the Smart Disclosure 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 Smart Disclosure 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 Smart Disclosure. The results of these activities demonstrate that
the Smart Disclosure is safe and effective when used in accordance with its
intended use and labeling. |
| | Therefore, the Smart Disclosure is considered substantially equivalent to the
predicate device. |
3
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.
4
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
5
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 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. |
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