(129 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of a traditional intramedullary nail system, with no mention of AI or ML.
Yes
The device is intended to treat stable and unstable fractures of the proximal femur, and various other fractures and non-unions, which falls under the definition of therapeutic use for restoring structure and function after injury or disease.
No
An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures. It is a therapy device, not a diagnostic device.
No
The device description explicitly states it consists of metal rods, blades, bolts, and caps, which are hardware components. The performance studies also focus on the mechanical properties of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for treating bone fractures. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a metal rod implanted into the bone. This is a surgical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (inside the body) for surgical treatment.
N/A
Intended Use / Indications for Use
SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
Product codes
HSB, HWC
Device Description
An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. SGM Femoral Nail System consists of a series of metal rods, proximal helical blades, bone locking bolts and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations. The implantable devices are manufactured from titanium alloy and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal femur, trochanteric and diaphyseal regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare facility/Hospital
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
• Performance-bench test including: Static Four-Point Bending Test per ASTM F1264-16 Static Torsional Test per ASTM F1264-16 Bending Fatigue Test per ASTM F1264-16 Bending Fatigue Test of Locking Screws per ASTM F1264-16 Cut-out Test of Helical Blade per ASTM F1264-16 Torsional Properties Test of the Locking Bolt per ASTM F543-17 Driving Torque Test of the Locking Bolt per ASTM F543-17 Axial Pullout Strength Test of the Locking Bolt per ASTM F543-17 Self-Tapping Performance Test of the Locking Bolt per ASTM F543-17 Single Cycle Construct Strength Test per ASTM F384-17 Construct Fatigue Strength Test per ASTM F384-17 •Reprocessing and sterilization SGM Femoral Nail System must be cleaned and sterilized prior to use. Geasure completed manual cleaning and steam sterilization validation testing per FDA guidance document, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued March 17, 2015. Validation testing confirmed the reprocessing instructions provided by Geasure achieve sterility of the implant and surgical instruments prior to use. No animal study data is submitted in this 510(k). No clinical study data is submitted in this 510(k).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
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June 30, 2023
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd % Xiaoqing Xue Registration Engineer Sinow Medical AS Høyteknologisenteret, Thormøhlens Gate 55, 5008 Bergen, Norway
Re: K230456
Trade/Device Name: SGM Femoral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: June 27, 2023 Received: June 27, 2023
Dear Xiaoqing Xue:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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Joseph P. Russell Digitally signed by Joseph P. Russell -S Date: 2023.06.30 08:56:29 -04'00'
For: Farzana Sharmin, Ph.D. Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230456
Device Name SGM Femoral Nail System
Indications for Use (Describe)
SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
K230456
| Preparation Date: | May.29, 2023 | |
|---|---|---|
| Submitter: | Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | |
| Address: No. 12, Jinfeng Road, West Taihu Science and Technology | ||
| Industrial Park, Changzhou, Jiangsu, P.R. China | ||
| Applicant Contact | Jing Huang, Management Representative | |
| Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. | ||
| Address: No. 12, Jinfeng Road, West Taihu Science and Technology | ||
| Industrial Park, Changzhou, Jiangsu, P.R. China | ||
| Postcode: 213149 | ||
| Email: huangjing@geasure.com | ||
| Phone:+86 13656146897 | ||
| Designated | ||
| Submission | ||
| Correspondent | Company: Sinow Medical AS | |
| Address: Høyteknologisenteret, Thormøhlens Gate 55, 5008, Bergen, | ||
| Norway | ||
| Contact Person: Xiaoqing Xue | ||
| Telephone: +86 15161196032 | ||
| Email: xue@bergemed.com | ||
| Subject Device | Name of Device | SGM Femoral Nail System |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3020 and 888.3040 | |
| Product Codes | HSB, HWC | |
| Classification Name | Intramedullary fixation rod; | |
| Smooth or threaded metallic bone fixation | ||
| fastener | ||
| Classification Panel | Orthopedic | |
| Common Name | Rod, Fixation, Intramedullary And Accessories; | |
| Screw, Fixation, Bone | ||
| Primary Predicate | ||
| Device | Manufacturer | Synthes (USA) |
| Name of Device | Synthes (USA) Trochanteric Fixation Nail (TFN) | |
| System | ||
| 510(K) Number | K011857 | |
| Regulatory Class | II | |
| Regulation Number | 21 CFR 888.3020 and 888.3040 | |
| Product Codes | HSB, HWC | |
| Classification Name | Intramedullary fixation rod; | |
| Smooth or threaded metallic bone fixation | ||
| fastener | ||
| fastener | ||
| Classification Panel | Orthopedic | |
| Common Name | Rod, Fixation, Intramedullary And Accessories; | |
| Screw, Fixation, Bone | ||
| Intended Use / | ||
| Indications for Use | SGM Femoral Nail System is intended to treat stable and unstable | |
| fractures of the proximal femur including pertrochanteric fractures, | ||
| intertrochanteric fractures, basal neck fractures, and combinations | ||
| thereof. The long SGM Femoral Nail is additionally indicated for | ||
| subtrochanteric fractures, pertrochanteric fractures associated with shaft | ||
| fractures, pathologic fractures (including prophylactic use) in both | ||
| trochanteric and diaphyseal regions, long subtrochanteric fractures, | ||
| proximal or distal non-unions, malunions, and revisions. | ||
| Device Description | An intramedullary fixation nail is a metal rod implanted into the | |
| medullary cavity of a bone to treat fractures that occur in long bones of | ||
| the body. SGM Femoral Nail System consists of a series of metal rods, | ||
| proximal helical blades, bone locking bolts and end caps. The rods are | ||
| cannulated and are provided with screw holes to accommodate screws of | ||
| various diameters and lengths. The rods are available in a range of sizes | ||
| used for specific anatomic locations and fracture configurations. The | ||
| implantable devices are manufactured from titanium alloy and are | ||
| provided non-sterile. | ||
| Mechanism of | ||
| Action | The SGM Femoral Nail System permits an intramedullary approach for | |
| the fixation of fractures of the femur. The SGM Femoral Nail System | ||
| consists of a series of cannulated nails, cannulated helical blades, | ||
| cannulated end caps, and locking bolts. The helical blade provides | ||
| resistance to varus collapse and rotational control of the medial fracture | ||
| segment compared to single screw fixation. The end cap is designed for | ||
| proximal closure of the nail to prevent bone ingrowth. | ||
| Materials | Titanium alloy (Ti-6Al-4V) ELI | |
| Coatings/Colorants | The devices are colored using an anodizing manufacturing process. No | |
| coatings or colorants are added to the device with this process. | ||
| Patient Contact | Bone and surrounding tissue | |
| Contact Duration | Permanent (>30 days) | |
| Sterilization | ||
| Method | The devices are provided non-sterile. Validated manual cleaning and | |
| steam sterilization instructions are provided for the end user before | ||
| implantation. | ||
| Environment of Use | Healthcare facility/Hospital | |
| Single Use | Yes | |
| End cap | Length: 0mm, 5mm and 10mm | |
| Helical Blades | Length:75mm-120mm | |
| Diameter:Ø11mm | ||
| Locking bolt | Length:26mm-100mm | |
| Diameter: Ø4.9mm | ||
| Intramedullary | ||
| fixation nails | Length:short 170mm, 200mm and 235mm; long 320mm-420mm | |
| Diameter: Ø10mm, Ø11mm,Ø12mm | ||
| angle | 130° | |
| Performance - | ||
| Animal | No animal study data is submitted in this 510(k). | |
| Summary of | ||
| intended use and | ||
| technological | ||
| characteristics | The SGM Femoral Nail System is substantially equivalent to the | |
| predicate device when evaluating intended use and technological | ||
| characteristics. | ||
| The subject device has the identical intended use as the predicate device. | ||
| The subject device and predicate devices are substantially equivalent | ||
| with only minor differences in technological characteristics regarding: | ||
| • Intramedullary Fixation Nail size | ||
| • Helical Blade size | ||
| • Locking Bolt size | ||
| These differences do not raise different questions of safety and | ||
| effectiveness. | ||
| Non-clinical test | • Performance-bench test including: | |
| Static Four-Point Bending Test per ASTM F1264-16 | ||
| Static Torsional Test per ASTM F1264-16 | ||
| Bending Fatigue Test per ASTM F1264-16 | ||
| Bending Fatigue Test of Locking Screws per ASTM F1264-16 | ||
| Cut-out Test of Helical Blade per ASTM F1264-16 | ||
| Torsional Properties Test of the Locking Bolt per ASTM F543-17 | ||
| Driving Torque Test of the Locking Bolt per ASTM F543-17 | ||
| Axial Pullout Strength Test of the Locking Bolt per ASTM F543-17 | ||
| Self-Tapping Performance Test of the Locking Bolt per ASTM | ||
| F543-17 | ||
| Single Cycle Construct Strength Test per ASTM F384-17 | ||
| Construct Fatigue Strength Test per ASTM F384-17 | ||
| •Reprocessing and sterilization | ||
| SGM Femoral Nail System must be cleaned and sterilized prior to use. | ||
| Geasure completed manual cleaning and steam sterilization validation | ||
| testing per FDA guidance document, Reprocessing Medical Devices | ||
| in Health Care Settings: Validation Methods and Labeling, issued | ||
| March 17, 2015. Validation testing confirmed the reprocessing | ||
| instructions provided by Geasure achieve sterility of the implant and | ||
| surgical instruments prior to use. | ||
| Performance - | ||
| Clinical | No clinical study data is submitted in this 510(k). | |
| Conclusion | The non-clinical data demonstrates the SGM Femoral Nail System is | |
| substantially equivalent to the predicate device |
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