(30 days)
No
The document describes a mechanical device (Inflation Device/Pump) used with intramedullary nailing systems for fracture fixation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The focus is on materials, design revisions, and substantial equivalence to previously cleared mechanical devices.
Yes
The device, described as an "Inflation Device (Nail Pump/Hip Peg Pump)" and part of "Fixion Systems," is indicated for the treatment of various fractures, non-unions, and arthritic conditions in the hip, femur, tibia, and humerus. These indications are clear signs of its therapeutic purpose, which is to alleviate or cure a disease or medical condition.
No
The device is described as an "Inflation Device (Nail Pump/Hip Peg Pump)" and its intended use is for treating fractures, non-unions, aseptic necrosis, and arthritis in the hip, femur, tibia, and humerus. These indications are for treatment, not diagnosis. The device description explicitly states it is part of a "Fixion Systems" for "Nailing System," which suggests a surgical or therapeutic purpose rather than a diagnostic one.
No
The device description explicitly mentions "Inflation Device (Nail Pump/Hip Peg Pump)" and discusses "new materials and a slightly revised design," indicating a physical hardware component. The comparison to predicate devices also focuses on implants and instrumentation sets, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the treatment of fractures, non-unions, aseptic necrosis, and arthritis in the hip, femur, tibia, and humerus. These are all conditions related to the musculoskeletal system and its repair.
- Device Description: The device is described as an "Inflation Device (Nail Pump/Hip Peg Pump)" used with "Fixion Systems" which are "Interlocking Proximal Femoral Intramedullary Nailing Systems" and "Hemi-Hip Systems". These are all surgical implants and associated instrumentation used in vivo (within the body) for orthopedic procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside the body on biological samples. This device is clearly designed for surgical implantation and manipulation inside the body.
N/A
Intended Use / Indications for Use
Hip:
- femoral head/neck fractures or non-unions; . I
- aseptic necrosis of the femoral head/neck; and
- osteo-, theumatoid, and post-traumatic arthritis of the hip, with mimmal acetabular involvement
Femur:
- ー fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures: proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- = use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- ー mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures; ー
- fixation of short distal or proximal fragments -
Tibia:
- diaphyseal shaft fractures in the tibia: -
- comminuted shaft fractures: ー
- fixation of short distal or proximal fragments
Humerus:
- ー diaphyseal shaft fractures in the humerus:
- comminuted shaft fractures:
- fixation of short distal or proximal fragments -
Product codes (comma separated list FDA assigned to the subject device)
HSB, JDS, KWY
Device Description
The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems. The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified Pump) has the following similarities to that which previously received 510(k) clearance; Have the same intended use - Have the same operating principles l - The Implants and the Instrumentation Set incorporate the same design ー - The Implants and the Instrumentation Set incorporate the same materials - The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip, Femur, Tibia, Humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K990717, K003212, K003215, K010901, K021324, K002783, K013449, K014072
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
NOV 1 4 2002
| Disc-O-Tech Medical Technologies, Ltd. |
|---|
| Fixion Interlocking Proximal Femur Intramedullary Nailing System |
510(k) Summary
Disc-O-Tech Medical Technologies, Ltd. Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System
Company Name
Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728
Submitter's Name and Contact Person
Yael Rubin Disc-O-Tech Medical Technologies, Ltd. 3 Hasadnaot St., Herzliya Israel, 46728 Tel: +972 9 9511511 Fax: +972 9 9548939
Date Prepared
October 2002
Trade/Proprietary Name
Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion Interlocking Intramedullary Nailing System; Fixion" Unipolar Modular Hemi-Hip System
Classification Name
21 CFR & 888.3020, Class II, Intramedullary fixation rod
21 CFR § 888.3390, Class II, Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis
Predicate Devices
Performance Standards
The following standards were used:
-
- The Fixion PF Nail is manufactured from 316L Stainless Steel, which meets the requirements of ASTM F 138 Standard Specification for Stainless Steel Bar and Wire for Surgical Implants.
-
- The Fixion PF Nailing System accessories incorporate surgical grade Stainless Steel, Silicone
1
and Celeron. '
-
- The Fixion PF Nailing System is designed to meet the requirements of ASTM F 565 Standard Practice for Care and Handling of Orthopedic Implants and Instruments.
Intended Use
Hip:
- femoral head/neck fractures or non-unions; . I
- aseptic necrosis of the femoral head/neck; and
- osteo-, theumatoid, and post-traumatic arthritis of the hip, with mimmal acetabular involvement
Femur:
- ー fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures: proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- = use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures, and revision procedures in the femur;
- ー mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures; ー
- fixation of short distal or proximal fragments -
Tibia:
- diaphyseal shaft fractures in the tibia: -
- comminuted shaft fractures: ー
- fixation of short distal or proximal fragments
Humerus:
- ー diaphyseal shaft fractures in the humerus:
- comminuted shaft fractures:
- fixation of short distal or proximal fragments -
Substantial Equivalence
The Inflation Device (Nail Pump/Hip Peg Pump), which incorporates new materials and a slightly revised design, is still intended to operate in a manner similar to the Purnp currently used with the aforementioned Fixion Systems and all materials incorporated into it are already used in instrumentation supplied with those systems.
The Fixion Interlocking Proximal Femoral Intramedullary Nailing System is substantially equivalent to the following cleared Fixion Systems: Fixion IM Nailing System - K990717. K003212, K003215, K010901, K021324; Fixion IL Nailing System - K002783, K013449; and Fixion UH Hemi-Hip System - K014072. The modified Fixion PF Nailing System (modified
2
Page 3 of 3
Disc-O-Tech Medical Technologies, Ltd. Fixion Interlocking Proximal Femur Intramedullary Nailing System
Pump) has the following similarities to that which previously received 510(k) clearance;
- Have the same intended use -
- Have the same operating principles l
- The Implants and the Instrumentation Set incorporate the same design ー
- The Implants and the Instrumentation Set incorporate the same materials -
- The Implants and the Instrumentation Set have the same basic packaging and sterilization, using the same materials and processes.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three parallel lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
NOV 1 4 2002
9200 Corporate Bouleva Rockville MD 20850
Ms. Yael Rubin Director of Regulatory Affairs Disc-o-Tech Medical Technologies, Ltd. 3 Hasadnaot St. Herzliya 46728 ISRAEL
Re: K023437
Trade/Device Name: Fixion™ Interlocking Proximal Femoral Intramedullary Nailing System; Fixion™ Intramedullary Nailing System; Fixion™ Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System
Regulation Number: 21 CFR 888.3020; 21 CFR 888.3390
Regulation Name: Intramedullary fixation rod; Hip joint (hemi-hip) metal/polymer cemented or uncemented prosthesis
Regulatory Class: Class II
Product Code: HSB, JDS, KWY Dated: October 10, 2002
Received: October 15, 2002
Dear Ms. Rubin:
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 enclosures) 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.
4
Page 2 - Ms. Yael Rubin
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. 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 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
5
510(k) Number (if known): K023437
Device Name: Fixion® Interlocking Proximal Femoral Intramedullary Nailing System; Fixion® Intramedullary Nailing System; Fixion® Interlocking Intramedullary Nailing System; Fixion™ Unipolar Modular Hemi-Hip System
Indications For Use: These devices are indicated for the following:
Hip:
- femoral head/neck fractures or non-unions; -
- aseptic necrosis of the femoral head/neck; and -
- osteo-, rheumatoid, and post-traumatic arthritis of the hip, with minimal acetabular involvement
Femur:
- fractures in the femur shaft, proximal femoral fractures, and combinations of these fractures; l proximal femoral fractures including stable and unstable pertrochanteric, intertrochanteric, and subtrochanteric (with and without break-off of the minor trochanter), high subtrochanteric fractures and combinations of these fractures;
- use in osteotomy, nonunions, bone reconstruction following turnor resection, ー grafting and pathological fractures, and revision procedures in the femur;
- mid shaft fractures in the femur (5 cm below the surgical neck to 5 cm proximal to the distal end of the medullar canal);
- comminuted shaft fractures: -
- fixation of short distal or proximal fragments -
Tibia:
- diaphyseal shaft fractures in the tibia: -
- comminuted shaft fractures; -
- fixation of short distal or proximal fragments a
Humerus:
- diaphyseal shaft fractures in the humerus; -
- comminuted shaft fractures;
- fixation of short distal or proximal fragments -
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-the-Counter Use |
|---|---|---|
| (Per 21 CFR § 801.109) | (Optional Format 1-2-96) |
(Division Sign-Off)
Division of General, Restorative
and No Rogical Devices
| 510(k) Number | K023437 |
|---|---|
| --------------- | --------- |