(131 days)
Not Found
No
The device is a mechanical implant and the summary does not mention any AI/ML components or functions.
No
The device is described as a permanent implant for sternal closure, not for treating a disease or condition in a therapeutic manner.
No
The device is a permanent implant used for sternal closure and is not described as gathering information about a patient's health condition to diagnose a disease or condition.
No
The device description explicitly states it is a permanent, medical grade 316L stainless steel implant, which is a hardware component.
Based on the provided information, the Figure 8 Sternotomy Closure Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sternal closure procedures," which is a surgical procedure performed on the patient's body.
- Device Description: The device is described as a "permanent, medical grade 316L stainless steel implant intended for use in sternal closure following median sternotomy." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Figure 8 Sternotomy Closure Device is a surgical implant used to physically close the sternum.
N/A
Intended Use / Indications for Use
The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The Figure 8 Sternotomy Closure Device ("Figure 8 SCD") is a permanent, medical grade 316L stainless steel implant intended for use in sternal closure following median sternotomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternal
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, sample size, AUC, MRMC, standalone performance, key results)
All necessary bench testing was conducted on the Figure 8 SCD to support a determination of substantial equivalence to the predicate device, including:
- Simulated Use Testing .
- Functional Verification Testing .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
Figure 8 Surgical, Inc.
JUL - 6 2011
FIGURE 8 STERNOTOMY CLOSURE DEVICE 510(k) PREMARKET NOTIFICATION
SECTION 5 510(k) Summary
510(k) Notification K_| | 054 |
GENERAL INFORMATION
Applicant:
Figure 8 Surgical, Inc. 890A Santa Cruz Avenue Menlo Park, CA 94025 U.S.A. Phone: 304-777-4677 Fax: 304-777-4679
Contact Person:
Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089-1330 U.S.A. Phone: 408-400-0856 ext. 112 Fax: 408-400-0865 Email: kitc@experiengroup.com
Date Prepared: February 24, 2011
DEVICE INFORMATION
Classification:
21 CFR§888.3010, Class II
Product Code:
JDQ
Trade Name: Figure 8 Sternotomy Closure Device
Generic/Common Name:
Bone Fixation Cerclage
1
FIGURE 8 STERNOTOMY CLOSURE DEVICE 510(k) PREMARKET NOTIFICATION
SECTION 5 510(k) SUMMARY
PREDICATE DEVICE
Ethicon Surgical Stainless Steel Suture (K931271)
INTENDED USE
The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
PRODUCT DESCRIPTION
The Figure 8 Sternotomy Closure Device ("Figure 8 SCD") is a permanent, medical grade 316L stainless steel implant intended for use in sternal closure following median sternotomy.
SUBSTANTIAL EQUIVALENCE
The indications for use for the Figure 8 SCD are substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the Figure 8 SCD is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the Figure 8 SCD to support a determination of substantial equivalence to the predicate device, including:
- Simulated Use Testing .
- Functional Verification Testing .
SUMMARY
The Figure 8 SCD is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Figure 8 Surgical, Inc. % Mr. Kit Cariquitan Regulatory Consultant 890A Santa Cruz Avenue Menlo Park, California 94025
JUL - 6 2011
Re: K110541
Trade/Device Name: Figure 8 Sternotomy Closure Device Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: June 22, 2011 Received: June 23, 2011
Dear Mr. Cariquitan:
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 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Kit Cariquitan
forth in the quality systems (OS) 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/CDRH/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Eric S. Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K | 054 |
Device Name: Figure 8 Sternotomy Closure Device
Indications For Use:
The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for M.Mekerson
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number __
22