(219 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on "digital planimetry software" for measurement and tracking, without mentioning any AI/ML capabilities.
No
The device is used for wound measurement and documentation, which aids in diagnosis and monitoring, but it does not directly treat or cure any condition.
No
Explanation: The device is indicated for wound measurement and documentation, which is a monitoring function rather than a diagnostic one.
Yes
The device description explicitly states "PictZar® is digital planimetry software". There is no mention of any accompanying hardware component being part of the device itself. While it likely uses hardware (like a camera for images), the device being cleared is the software for measurement and tracking.
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" on "external wound types." This describes a device used to assess and record information about a wound on the surface of the body.
- Device Description: The device is described as "digital planimetry software used for the measurement and tracking." Planimetry is the measurement of area, which aligns with the wound measurement intended use.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with bodily specimens or diagnostic purposes based on analyzing such specimens.
The device's function is focused on external measurement and documentation, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
PictZar is indicated for wound measurement and documentation and can be used on all external wound types.
The intended use of PictZar® planimetry software is to measure and document the progression of external wounds over time. This system is a computer software application. The system is a non-contact method of wound measurement.
Product codes
FXN
Device Description
PictZar® is digital planimetry software used for the measurement and tracking
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)
Not Found
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
510(k) Summary for K130165
| Submitter: | Advanced Planimetric Services, LLC | |
|---|---|---|
| Address: | 610 Boulevard, Elmwood Park, New Jersey 07407 | |
| Telephone: | 646-220-1745 | |
| Contact Person: | Dr. Martin Wendelken | |
| Date of Summary: | 28- August- 2013 | AUG 30 2013 |
| Trade Name: | PictZar® | |
| Common Name: | Wound measurement and documentation software | |
| Classification Name: | Surgical camera and accessories (21CFR878.4160) | |
| Class : | Class I (general controls) | |
| Predicate Devices: | Verg Videometer (Verg Incorporated) | |
| Visitrak (Smith & Nephew) | ||
| Silhouette (Aranz Medical Ltd.) | ||
| Device Description: | PictZar® is digital planimetry software used for the measurement and tracking | |
| Indications for Use: | PictZar is indicated for wound measurement and documentation | |
| and can be used on all external wound types. | ||
| Intended Use: | The intended use of PictZar® planimetry software is to measure and | |
| document the progression of external wounds over time. This system | ||
| is a computer software application. The system is a non-contact method | ||
| of wound measurement. | ||
| Comparison to | ||
| Predicates: | PictZar® is substantially equivalent to the predicate devices in the | |
| comparison of the indications for use, the intended use, how it is | ||
| used relating to workflow using current principals and technology. | ||
| Measurements made PictZar® are equal to or more accuate than those | ||
| made with the predicate devices. The differences do not raise any | ||
| questions of safety and effectiveness over the predicate devices. |
.
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Advanced Planimetric Services, LLC Dr. Martin E. Wendelken President 610 Boulevard Elmwood Park, New Jersey 07407
August 30, 2013
Rc: K130165
Trade/Device Name: PictZar® Digital Planimetry Software Application Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: Class I Product Code: FXN Dated: May 27, 2013 Received: June 05, 2013
Dear Dr. Wendelken:
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 cnclosure) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Dr. Martin E. Wendelken
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number: K130165
Device Name: PictZar® Digital Planimetry Software and Documentation System
Indications For Use:
PictZar® planimetry software is indicated for wound measurement and documentation and can be used on all external wound types.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
Neil R Ogden: 2013.08.30 12:49:15 -04'00'
(Division Sign-Off) for MXM ·
Division of Surgical Devices
510(k) Number_K130165