(53 days)
The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.
The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.
The provided text describes a Special 510(k) Device Modification for the "Pioneer SilCoat Sternal Cable," which is a modification of the previously cleared "Songer™ Sternal Cable System." The submission aims to demonstrate substantial equivalence of the modified device.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Metric | Study Acceptance Criteria | Reported Device Performance (Pioneer SilCoat Sternal Cable) |
|---|---|---|---|
| Mechanical Performance (Static) | Yield Load Comparison | No specific numerical acceptance criteria explicitly stated, but the goal is "no difference" compared to the predicate device. | ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. |
| Mechanical Performance (Fatigue) | Fatigue Life | No specific numerical acceptance criteria explicitly stated, but the goal is "equivalent" to the predicate device. | Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The text only mentions "static tests" and "fatigue life curves" without specifying the number of cables or tests performed.
- Data Provenance: The studies were conducted by "Pioneer Surgical Technology" as part of their 510(k) submission. These are likely prospective bench tests performed in a controlled laboratory environment. The country of origin is not explicitly stated, but Pioneer Surgical Technology is based in Marquette, Michigan, USA, suggesting the tests were likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This study involves bench testing of mechanical properties of a medical device (cables), not interpretation of medical images or clinical data by experts. Therefore, there is no "ground truth" to be established by medical experts in the context of this performance data. The "ground truth" here is the physical measurement of the mechanical properties.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a bench test of mechanical properties, there is no need for an adjudication method as would be used for subjective assessments or ambiguous clinical data. The results are quantitative measurements.
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
- No. This is a submission for a modified medical device (sternal cable), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm. Standalone performance studies typically refer to the performance of an AI algorithm without human input, which is not relevant here.
7. The Type of Ground Truth Used
- The "ground truth" for this performance study is established by objective, quantitative mechanical measurements of the physical properties (yield load, fatigue life) of the sternal cables. This is based on standard engineering and materials science principles and testing methodologies.
- For yield load, the ground truth is the measured force at which the cable begins to deform plastically.
- For fatigue life, the ground truth is the measured number of cycles a cable can withstand before failure under specified load conditions.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device modification. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant for demonstrating substantial equivalence of a physical medical device through bench testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not applicable.
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NOV 23 1999
SPECIAL 510(k) DEVICE SUMMARY VI.
Pioneer Surgical Technology Special 510(k): Device Modification For Pioneer SilCoat Sternal Cable
ADMINISTRATIVE INFORMATION
| Manufacturer IdentificationAnd Sponsor | Pioneer Surgical Technology375 River Park CircleMarquette, Michigan 49855-1781Telephone: (906) 226-9909Facsimile: (906) 226-9932 |
|---|---|
| Official Contact | Amy H. Mommaerts, ManagerRegulatory Affairs |
Date Prepared
September 30, 1999
MODIFIED DEVICE IDENTIFICATION
| Proprietary Name | Pioneer SilCoat Sternal Cable |
|---|---|
| Common Name | Cerclage, Bone Fixation |
| Classification NameAnd Reference | Cerclage, Bone FixationRegulation Number: CFR 888.3010Classification Number: 87JDQ II |
| Previously Cleared DeviceName and 510(k) Numbers | SONGER™ Cable System:K922952; K935481; and K941213 |
Modified Device Description
The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.
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Intended Use
The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.
Technological Characteristic Compared to Previously Cleared Device
Pioneer Surgical Technology considers the SilCoat cable to be substantially equivalent in function, design, and use to the Songer™ Sternal Cable System without the silver coating.
Performance Data
Static tests comparing the Songer™ Sternal Cable System with the Pioneer SilCoat cable system show they are similar. An ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct.
Pioneer Surgical Technology makes no claim in regard to the silver coated cables effect on reducing infection. No clinical studies have been performed to make any such claims.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three wavy lines representing the body and head. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1999
Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-0627
K993286 Re: Pioneer SilCoat Sternal Cable Trade Name: Regulatory Class: II Product Code: JDQ Dated: November 10, 1999 November 12, 1999 Received:
Dear Ms. Mommaerts:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Ms. Amy H. Mommaerts
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Neil R.P. Ogden for
James F. Dillard III
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Pioneer Surgical Technology
Indications for Use For Pioneer SilCoat Sternal Cable System
The Pioneer SilCoat Sternal Cable is indicated for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the stemum to promote fusion.
Nro for
(Division Off)
Director General Restorative Devices K993286
Divisiol 5 1.Jiki Number -
ర్య Prescription Use J (Per 21 CFR 801.109)
Pioneer Surgical Technology
§ 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.