(113 days)
The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.
HA Cortical Self-Tapping Bone Screws in diameters of 1.5mm to 5.0mm and lengths of 4mm to 90mm.
This 510(k) summary describes a medical device, the Ensplint™ Bone Screw, that is seeking clearance as substantially equivalent to a predicate device. The primary method for demonstrating substantial equivalence is through comparison to existing, legally marketed devices and adherence to relevant standards, rather than extensive new performance studies.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Equivalence | Utilizes the same material as the predicate device (Syntec Scientific Corp. Bone Screws). | The device "utilizes the same material" as the predicate. |
| Technology Characteristics | Utilizes the same technology characteristics as the predicate device. | The device "utilizes the same... technology characteristics" as the predicate. |
| Standard Conformance | Conforms to ASTM F543-2 Standard Specification for HA Bone Screws. | The device "conforms to the ASTM F543-2 Standard Specification for HA Bone Screws." |
| Dimensional Equivalence | Diameters and lengths are within the range of the predicate device (Syntec Scientific Corp. bone screws). | The device's "diameters and lengths are within the diameters and lengths of the predicate Syntec Scientific Corp bone screws." |
| Intended Use | Intended to treat fractures of various small and long bones; can also be used with the EnsplintRx Distal Radius System. (This is the intended use, and the declaration of substantial equivalence implies that the device meets this intended use based on the predicate comparison, rather than requiring specific performance metrics here). | The device's stated "Indications for Use" are: "The Ensplint™ Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System." |
Study that Proves Device Meets Acceptance Criteria:
The study proving the device meets the acceptance criteria is a comparison to a predicate device and adherence to an industry standard, rather than a clinical trial or a performance study generating new data. The rationale for substantial equivalence explicitly states:
"The Ensplint™ Bone Screw utilizes the same material and technology characteristics as the Syntec Scientific Corp. Bone Screws and conforms to the ASTM F543-2 Standard Specification for HA Bone Screws. The diameters and lengths are within the diameters and lengths of the predicate Syntec Scientific Corp bone screws. Therefore testing is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed bone screws."
This indicates that the "study" is a benchmarking and documentation exercise showing direct equivalence or adherence to established standards and the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a traditional performance "test set." The basis for clearance is comparison to a predicate device and adherence to a standard, not empirical testing of a "test set" of devices from this specific manufacturer. The "device performance" in the table above refers to descriptive characteristics matching the predicate/standard, not measured performance data from a specific test sample.
- Data Provenance: Not applicable for new data generation. The provenance stems from the characteristics of the predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495) and the published ASTM F543-2 standard. This is not prospective or retrospective patient data but rather existing device specifications and industry standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. There's no "ground truth" established by experts for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" for the equivalence claim is implicitly the established safety and effectiveness profile of the predicate device and the criteria defined in the ASTM standard.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" requiring adjudication in the context of this 510(k) submission.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- No. This is not a diagnostic imaging device or an AI-assisted tool where human reader performance would be a relevant metric.
6. Standalone Performance Study
- No, a standalone (algorithm only without human-in-the-loop performance) study was not done. The submission explicitly states "testing is not needed" due to direct equivalence to a predicate and conformance to a standard. This is a characteristic-based comparison.
7. Type of Ground Truth Used
- The "ground truth" in this context is based on:
- Predicate Device Characteristics: The established design, material, and technological specifications of the legally marketed predicate device (Syntec-Taichung Non-Sterile Bone Plate and Screw Implants, K983495).
- Industry Standard: The requirements and specifications outlined in the ASTM F543-2 Standard Specification for HA Bone Screws.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The device design is based on established engineering principles and comparison to an existing device, not on learning from a data set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device submission.
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510(K) SUMMARY
JUL 1 0 2008
| Submitter's name: | Sonoma Orthopedic Products, Inc. |
|---|---|
| Address: | 650 Larkfield Center, Suite CSanta Rosa, CA 95403 |
| Phone Number: | 707-526-1335 x-224 |
| Fax Number: | 707-526-2022 |
| Contact Person: | Amy ConuelDirector Quality Assurance & Regulatory Affairs |
| Date Prepared: | July 8, 2008 |
| Trade Name: | Ensplint™ Bone Screw |
| Common Name: | Bone Screw |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Predicate Device: | Syntec-Taichung Non-Sterile Bone Plate and ScrewImplants. K983495, cleared 12/16/1998 |
| Device Description: | HA Cortical Self-Tapping Bone Screws in diameters of1.5mm to 5.0mm and lengths of 4mm to 90mm. |
| Intended Use: | The Ensplint™ Bone Screws are intended to treat fracturesof various small and long bones. The Ensplint™ BoneScrews can also be used with the EnsplintRx Distal RadiusSystem. |
| Rationale for SubstantialEquivalence / Comparisonto Predicate: | The Ensplint™ Bone Screw utilizes the same material andtechnology characteristics as the Syntec Scientific Corp.Bone Screws and conforms to the ASTM F543-2 StandardSpecification for HA Bone Screws. The diameters andlengths are within the diameters and lengths of the predicateSyntec Scientific Corp bone screws. Therefore testing is notneeded to demonstrate that the subject devices aresubstantially equivalent to other legally marketed bonescrews. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sonoma Orthopedic Products, LLC % Ms. Amy Conuel Director, Quality Assurance/Regulatory Affairs 650 Larkfield Center, Suite C Santa Rosa, California 95403
JUL 1 0 2008
Re: K080778
Trade/Device Name: Ensplint™ Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: Class II Product Code: HWC Dated: June 24, 2008 Received: June 25, 2008
Dear Ms. Conuel:
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 such 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); 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.
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Page 2 - Ms. Amy Conuel
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Mullican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): K080778
Ensplint™ Bone Screw Device Name:
Indications for Use:
The Ensplint 114 Bone Screws are intended to treat fractures of various small and long bones. The Ensplint™ Bone Screws can also be used with the EnsplintRx Distal Radius System.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Saubare Briehm Dformm
Division of General, Restorative, and Neurological Devices
519(1) Number K080728
§ 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.