(131 days)
The Figure 8 Sternotomy Closure Device is indicated for use in sternal closure procedures.
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.
The provided document is a 510(k) Premarket Notification for the Figure 8 Sternotomy Closure Device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to establish specific acceptance criteria and performance metrics for the device itself. Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, and ground truth establishment are not present in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific acceptance criteria with quantifiable performance metrics (e.g., accuracy, sensitivity, specificity) for the device's clinical performance. Instead, it states that "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 and Functional Verification Testing." The success of these tests implies that the device met internal design specifications, but these specifications are not explicitly provided in this summary.
2. Sample size used for the test set and the data provenance
No human or animal test set data is presented in this 510(k) summary. The testing mentioned is "bench testing" (Simulated Use Testing and Functional Verification Testing), which typically involves laboratory-based evaluations of the device's physical and mechanical properties. Therefore, there's no information about the provenance of data as it's not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no clinical test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set
This information is not applicable as no clinical test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a surgical sternotomy closure device, not an AI-assisted diagnostic or assistive technology targeting human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is a physical medical implant, not an algorithm.
7. The type of ground truth used
For the "Simulated Use Testing" and "Functional Verification Testing" mentioned, the ground truth would likely refer to engineering specifications, mechanical testing standards, or predefined biomechanical outcomes that the device is intended to meet. These specifics are not detailed in the summary.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" in the context of this physical device's evaluation.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
Summary of the Study:
The "study" referenced in this 510(k) is a series of bench tests (Simulated Use Testing and Functional Verification Testing) conducted to demonstrate substantial equivalence of the Figure 8 Sternotomy Closure Device to a predicate device (Ethicon Surgical Stainless Steel Suture, K931271). This means the focus was on showing that the new device has similar technological characteristics and is as safe and effective as the already-marketed predicate device, rather than establishing de novo performance metrics against specific, prospective clinical endpoints. The specific details of these bench tests, the exact acceptance criteria for those tests, and the results are not included in this summary. The core of the submission is the claim of substantial equivalence, supported by the statement that "Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness."
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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
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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.
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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
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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
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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
§ 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.