(212 days)
Not Found
No
The device description and performance studies focus on the physical properties and placement of a gold tissue marker, with no mention of AI or ML for image analysis, diagnosis, or any other function.
No
The device is used to mark soft tissue for radiographic imaging during or after a surgical procedure, not to treat a disease or condition.
No
The device is used to mark soft tissue for radiographic visualization, not to diagnose a condition.
No
The device description explicitly states it is comprised of a gold marker and a disposable delivery device, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue during a surgical procedure or for future surgical procedures." This describes a device used in vivo (within the body) for marking purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a device for placing a marker into soft tissue. This is consistent with an in vivo application.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue samples, etc.) or performing diagnostic tests in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for marking a location within the body for imaging purposes.
N/A
Intended Use / Indications for Use
The CareFusion Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
The Gold Tissue Marker is a sterile, single use device comprised of a gold marker and disposable delivery device. The delivery device has 1cm reference marks and echogenic marks on the distal tip to aid in ultrasound guided marker placement. The Gold Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound, radiography, Magnetic Resonance Imaging (MRI)
Anatomical Site
soft tissue
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
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
- Biocompatibility: AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: Evaluation and Testing; AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - Part 6 Tests for Local Effects After Implantation; AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 Tests for Systemic Toxicity; AAMI/ANSI/ISO 10993-18: 2006 Biological Evaluation of Medical Devices - Part 18 Chemical Characterization of Materials
- Residuals: AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals
- Performance: ISO 14630: 2012: Non-active Surgical Implants - General Requirements; ASTM F72: 2006 Section 4: Standard Specification for Gold Wire for Semiconductor Lead Bonding; ASTM F2052: 2006: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the MR Environment; ASTM F2119: 2007: Standard Test Method for the Evaluation of MR Image Artifacts from Passive Implants; ASTM F2182: 2011A: Standard Test Method for the Measurement of Radio frequency Induced Heating on or Near Passive Implants During MRI; ASTM F2213: 2006, RA 2011: Standard Test Method for the Measurement of Magnetically Induced Torque on Medical Devices in the MR Environment; BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical Devices; ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 & 2; ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide Sterilization; AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide Sterilization; Bench Top Testing – Marker securement, force to deploy, dimensional verification, and strength of connections; Simulated Use - Implantation, visualization under ultrasound, MRI and radiograph, marker integrity after repeated compression
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION:
N/A - No clinical tests were conducted for this submission.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA:
The results of the non-clinical tests show that the CareFusion Gold Tissue Marker meets or exceed all performance requirements, and is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image contains the logo for the Department of Health and Human Services (HHS) in the United States. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three profiles merging to form a single, unified image. The profiles are facing to the right and are meant to represent the department's commitment to health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2015
CareFusion Ms. Joy Greidanus Manager, Regulatory Affairs 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K141722
Trade/Device Name: CareFusion Gold Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NEU Dated: December 11, 2014 Received: December 15, 2014
Dear Ms. Greidanus:
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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K141722
Device Name CareFusion Gold Tissue Marker
Indications for Use (Describe)
The CareFusion Gold Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K141722
| SUBMITTER INFORMATION | ||
|---|---|---|
| Name | CareFusion | |
| Address | 75 North Fairway Drive, Vernon Hills, IL 60061 USA | |
| Phone number | (847) 362-8103 | |
| Fax number | (312) 949-0583 | |
| Establishment Registration | ||
| Number | 1423507 | |
| Name of contact person | Joy Greidanus | |
| Date prepared | January 14, 2015 | |
| DESCRIPTION OF DEVICE | ||
| Trade or proprietary name | CareFusion Gold Tissue Marker | |
| Common or usual name | Tissue Marker | |
| Classification name | Implantable Clip | |
| Classification panel | General & Plastic Surgery | |
| Regulation | Class II per 21CFR §878.4300, Procode NEU | |
| Product Code(s) | Multiple | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | K070436 Carbon Medical Technologies | |
| Reason for 510(k) submission | New product. | |
| Device description | The Gold Tissue Marker is a sterile, single use device comprised of a gold | |
| marker and disposable delivery device. The delivery device has 1cm | ||
| reference marks and echogenic marks on the distal tip to aid in ultrasound | ||
| guided marker placement. The Gold Tissue Marker is placed into soft | ||
| tissue during open, percutaneous, or endoscopic procedures to | ||
| radiographically mark a surgical location. | ||
| Intended use of the device | The Gold Tissue Marker is indicated for use to radiographically mark soft | |
| tissue during a surgical procedure or for future surgical procedures. | ||
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED | ||
| TO THE PREDICATE DEVICE | ||
| Characteristic | New Device | Predicates |
| Delivery device | Manual mechanism (plunger | |
| action) with stylet and | ||
| cannula | Same as predicate: K070436 Carbon | |
| Medical Technologies | ||
| Tissue marker | Implanted, gold | Same as predicate: K070436 Carbon |
| Medical Technologies | ||
| Visualization | Visible on standard | |
| radiographs, Magnetic | ||
| Resonance Imaging (MRI) | ||
| and ultrasound | Same as predicate: K070436 Carbon | |
| Medical Technologies |
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
4
| CONCLUSION OF DEVICE COMPARISON | |
|---|---|
| The technological characteristics of the proposed devices are substantially equivalent to the predicate. | |
| PERFORMANCE DATA | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | |
| SUBSTANTIAL EQUIVALENCE | |
| Characteristic | Standard/Test/FDA Guidance |
| Biocompatibility | AAMI/ANSI/ISO 10993-1:2009 Biological evaluation of Medical Devices Part 1: |
| Evaluation and Testing | |
| Biocompatibility | AAMI/ANSI/ISO 10993-6: 2007 (R) 2010 Biological Evaluation of Medical Devices - |
| Part 6 Tests for Local Effects After Implantation | |
| Residuals | AAMI/ANSI/ISO 10993-7:2008 Biological evaluation of Medical Devices Part 7: |
| Ethylene Oxide Sterilization Residuals | |
| Biocompatibility | AAMI/ANSI/ISO 10993-11: 2006 Biological Evaluation of Medical Devices - Part 11 |
| Tests for Systemic Toxicity | |
| Biocompatibility | AAMI/ANSI/ISO 10993-18: 2006 Biological Evaluation of Medical Devices - Part 18 |
| Chemical Characterization of Materials | |
| Performance | ISO 14630: 2012: Non-active Surgical Implants - General Requirements |
| Performance | ASTM F72: 2006 Section 4: Standard Specification for Gold Wire for Semiconductor |
| Lead Bonding | |
| Performance | ASTM F2052: 2006: Standard Test Method for Measurement of Magnetically Induced |
| Displacement Force on Medical Devices in the MR Environment | |
| Performance | ASTM F2119: 2007: Standard Test Method for the Evaluation of MR Image Artifacts |
| from Passive Implants | |
| Performance | ASTM F2182: 2011A: Standard Test Method for the Measurement of Radio frequency |
| Induced Heating on or Near Passive Implants During MRI | |
| Performance | ASTM F2213: 2006, RA 2011: Standard Test Method for the Measurement of |
| Magnetically Induced Torque on Medical Devices in the MR Environment | |
| Performance | BS EN ISO 9626:1995: Stainless Steel Needle Tubing for the Manufacture of Medical |
| Devices. | |
| Performance | ISO 11737-1,2:2006 Sterilization of Medical Devices - Microbiological Methods Part 1 |
| & 2 | |
| Performance | ISO 11135:2007 Medical Device, Validation and Routine Control of Ethylene Oxide |
| Sterilization | |
| Performance | AAMI TIR28:2009 Product Adoption and Process Equivalency for Ethylene Oxide |
| Sterilization | |
| Performance | Bench Top Testing – Marker securement, force to deploy, dimensional verification, and |
| strength of connections | |
| Performance | Simulated Use - Implantation, visualization under ultrasound, MRI and radiograph, |
| marker integrity after repeated compression | |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | |
| EQUIVALENCE AND/OR OF CLINICAL INFORMATION | |
| N/A - No clinical tests were conducted for this submission | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA |
The results of the non-clinical tests show that the CareFusion Gold Tissue Marker meets or exceed all performance requirements, and is substantially equivalent to the predicate devices.