(98 days)
The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.
The Emerge Medical Cannulated Bone Screw set consists of various size bone screws. The screws are available in a variety of sizes differing in diameter, overall length and threaded length. The screws are machined from 316 L stainless steel or titanium alloy. Each screw is cannulated with a hole through the center for use with appropriately sized guide wires. The screw heads have various configurations which mate with commonly used drivers. No specialized instruments are required for placement of the screws. The screws have mating washers which can be slipped over the shaft of the screw and fit under the screw head. The screws are used with generic instruments commonly available to orthopedic surgeons. The devices are provided both in non-sterile or in sterile packages as preferred by the user.
The provided text describes the "Emerge Medical - Cannulated Screw Fixation System (K102343)" and details its substantial equivalence to predicate devices. It focuses on the mechanical performance of the screws rather than the performance of an AI/ML-driven device. As such, many of the requested categories related to AI/ML device evaluation (like expert adjudication, MRMC studies, standalone algorithm performance, and ground truth creation for training/test sets) are not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria related to the device's physical performance and how it was proven to meet those criteria.
Description of the Acceptance Criteria and Study for the Emerge Medical Cannulated Screw Fixation System (K102343)
The Emerge Medical Cannulated Screw Fixation System is a Class II medical device intended for bone fixation. Its acceptance criteria and performance evaluation were based on demonstrating substantial equivalence to predicate devices through mechanical testing and material characteristics, rather than an AI/ML-driven performance study.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Test Description | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Screw Torsional Strength (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. |
| Screw Axial Pullout (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. | |
| Screw Driving and Removal Torque (Recognized Consensus Standard) | Shown to be substantially equivalent to predicate screws. | |
| Material Biocompatibility | Use of 316L stainless steel or titanium alloy | Materials "commonly used for orthopedic implants and have a long history of biocompatibility." |
| Design Similarity | Similar design to predicate devices | "Similar designs" to predicate devices. |
| Indications for Use | Aligned with predicate devices | "Similar indications" to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each mechanical test (e.g., number of screws tested for torsional strength, pullout, etc.). The provenance of the data is from non-clinical bench testing performed by the manufacturer, Emerge Medical, to demonstrate substantial equivalence. No information on country of origin or whether it was retrospective/prospective is applicable as it's a materials/mechanical stress test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the evaluation involved mechanical testing against recognized consensus standards and comparison to predicate devices, not expert human interpretation for a diagnostic or AI/ML-driven task.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI/ML system on human reader performance, which is not applicable to a bone screw fixation system.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
No, a standalone algorithm performance study was not done. This device is a physical medical implant, not an AI/ML algorithm. The "standalone" performance here refers to the physical attributes of the screw itself as tested in a lab.
7. The Type of Ground Truth Used:
The "ground truth" for this device's acceptance was established by:
- Recognized consensus standards: The mechanical tests (Torsional Strength, Axial Pullout, Driving and Removal Torque) were performed against these established standards.
- Performance of legally marketed predicate devices: The Emerge Medical screws were deemed "substantially equivalent" when compared to the performance of predicate devices such as the Synthes Cannulated Screw System (various K-numbers provided). This means the predicate device performance implicitly served as a benchmark for what was acceptable.
8. The Sample Size for the Training Set:
This concept is not applicable as there is no "training set" in the context of a physical device like a bone screw.
9. How the Ground Truth for the Training Set Was Established:
This concept is not applicable for the same reasons as point 8.
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510(k) Summary
NOV 2 3 2010
Emerge Medical - Cannulated Screw Fixation System (K102343)
Nov. 11.2010
Submitter/Regulatory Contact:
Curtis Raymond - Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: (203) 922-0105
Sponsor/Manufacturer:
Emerge Medical 1530 Blake Street - Suite 204 Denver, CO 80202
FDA Establishment Registration Number: Awaiting Assignment Owner Operator Number: 10033339
Trade Name, Common Name, Classification:
Device Trade Name: Emerge Medical Cannulated Screw Fixation System
Device Common or Usual Names: Bone Fixation Screws
Classification: Class II
Classification Name: screw, fixation, bone
Regulation: 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener)
Product Code: HWC
Predicate Devices: Synthes Cannulated Screw System:
K962011 (7.0, 7.3mm) K962823 (3.0mm) K963172 (4.5mm) K963192 (3.5, 4.0mm) K012945 (2.4mm) K021932 (6.5mm)
Description of the Device:
The Emerge Medical Cannulated Bone Screw set consists of various size bone screws. The screws are available in a variety of sizes differing in diameter, overall length
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and threaded length. The screws are machined from 316 L stainless steel or titanium alloy.
Each screw is cannulated with a hole through the center for use with appropriately sized guide wires. The screw heads have various configurations which mate with commonly used drivers. No specialized instruments are required for placement of the screws.
The screws have mating washers which can be slipped over the shaft of the screw and fit under the screw head. The screws are used with generic instruments commonly available to orthopedic surgeons.
The devices are provided both in non-sterile or in sterile packages as preferred by the user.
Intended Use:
The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.
Technological Characteristics:
The subject device is substantially equivalent to the predicate devices. Both the subject device and predicate devices have a similar designs, materials and indications. The materials comprising the device (316L stainless steel or titanium alloy) are commonly used for orthopedic implants and have a long history of biocompatibility
Performance:
The devices have been subjected to recognized consensus standards and perform in a manner equivalent to the predicate devices. Testing included
Screw Torsional Strength,
Screw Axial Pullout,
Screw Driving and Removal Torque
In all instances. Emerge screws were shown to be substantially equivalent to the predicate screws.
Conclusion:
We believe that based on the predicate device comparison and the non-clinical testing performed the subject device is substantially equivalent to the predicate devices and conclude that the subject devices are as safe and effective as the predicate devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Emerge Medical % Orchid Design Mr. Curtis Raymond 80 Shelton Technology Center Shelton, CT 06484
NOV 2 3 2010
Re: K102343
Trade/Device Name: Emerge Medical Cannulated Screw Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 12, 2010 Received: November 15, 2010
Dear Mr. Raymond:
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
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Page 2 - Mr. Curtis Raymond
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 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/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/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Barbara Bonehp
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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Indications for Use
510(k) Number (if known): Klo23436pg /וֹ (
NOV 2 3 2010
Emerge Medical Cannulated Screw Fixation System Device Name:
Indications For Use:
The Emerge Medical Cannulated Screw Fixation System is intended to provide bone fixation in the management of fractures of both small and large bones and bone fragments, including those in the foot, patella, ankle, wrist, and elbow and arthrodesis of the foot, wrist, and elbow and small and long bone osteotomies.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Oneta for mxm
(Division Sign-Off)
Division of Surgical. Orthopedic, and Restorative Devices
510(k) Number K102343
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.