(136 days)
FXN
Not Found
No
The summary describes a camera and PDA for wound measurement and tracking, with no mention of AI, ML, or related concepts like image processing or training/test sets.
No
The device is used for wound measurement and documentation, which are diagnostic and monitoring functions, not therapeutic interventions.
No
The device is used for wound measurement and documentation, which is a monitoring function rather than making a diagnosis.
No
The device description explicitly states it consists of a camera connected to a PDA, indicating hardware components are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "wound measurement and documentation." This involves assessing the physical characteristics of a wound on the body, not analyzing biological samples (like blood, urine, tissue) outside of the body.
- Device Description: The device consists of a camera connected to a PDA for measurement and tracking. This describes a system for capturing and processing visual information from the wound surface.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. Silhouette's function is to measure and document the wound itself, which is an external assessment, not an analysis of a biological sample.
N/A
Intended Use / Indications for Use
Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.
Product codes
FXN
Device Description
Silhouette consists of a camera connected to a PDA, for the measurement and tracking of wounds
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
external wound types
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Verge Videometer, Visitrak
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
| K070426 | |||
|---|---|---|---|
| 510(k) Premarket Notification | QF-00 | ||
| Silhouette | 2007-00001 | ||
| aranz | |||
| applied research associates ltd | 510(k) Summary of Safety and | Rev: 1.0 | Approved |
510(k) Summary of Safety and Effectiveness
: •
| Submitter: | ARANZ Medical Limited | JUN 29 2007 |
|---|---|---|
| Address: | Ground Floor, St Elmo Courts | |
| 47 Hereford Street, PO Box 3894 | ||
| Christchurch 8013 | ||
| Phone: | +64 3 3746120 ext 217 | |
| Fax: | +64 3 3746130 | |
| Contact: | Shane Goodwin | |
| Trade name: | Silhouette | |
| Common name: | Wound measurement and documentation system | |
| Classification name: | Surgical camera and accessories (21 CFR 878.4160) | |
| Class: | Class I (general controls) | |
| Predicate Devices: | Verge Videometer (Verg Incorportated) | |
| Visitrak (Smith & Nephew) | ||
| Device Description: | Silhouette consists of a camera connected to a PDA, for the | |
| measurement and tracking of wounds | ||
| Indications for Use: | Silhouette is indicated for wound measurement and documentation | |
| and can be used on all external wound types. | ||
| Intended Use: | The intended use of the Silhouette system is to measure and | |
| document the progression of external wounds over time. The | ||
| Silhouette system is comprised of a camera (SilhouetteCamera) | ||
| connected to a PDA running a software application | ||
| (SilhouetteMobile Software) to capture and document images taken | ||
| by the user. A software accessory (SilhouetteServer) on a PC may | ||
| be used to transfer images and documentation to a third-party | ||
| patient information database. The system is non-contact with | ||
| respect to the patient. | ||
| Comparison to Predicates: | Silhouette is substantially equivalent the predicate devices, | |
| considered in light of the comparison of the indications for use, the | ||
| intended use, the workflow of the devices and the technological | ||
| principles being applied. Standard wound measurements made with | ||
| Silhouette are more accurate than those made with the predicate | ||
| devices. These differences do not raise questions safety and | ||
| effectiveness over the predicate devices. | ||
| Date of Summary: | 17 January 2007 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 2007
Aranz Medical Limited % Shane Goodwin Regulatory Scientist St. Elmo Courts Ground Floor 47 Hereford Street P.O. Box 3894 Christchurch, New Zealand
Re: K070426
Trade/Device Name: Silhouette Wound Measurement and Documentation System Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: I Product Code: FXN Dated: June 18, 2007 Received: June 20, 2007
Dear Shane Goodwin:
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.
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
2
Page 2 - Shane Goodwin
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) 276-0115. 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 vours
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K070426
Device Name: Silhouette Wound Measurement and Documentation System
Indications For Use:
Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.
| Prescription Use
(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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | 467424 |
|---|---|
| Page | 1 of 1 |