(181 days)
Not Found
No
The 510(k) summary describes a system of pre-contoured plates and screws for fracture repair and mentions Finite Element Analysis for mechanical testing, but there is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is indicated for treatment of fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus. This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a system of plates, screws, and instrumentation used for the mechanical repair of fractures, not for diagnosing conditions.
No
The device description explicitly details physical components including pre-contoured fracture plates, screws, and instrumentation, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical repair of fractures and other issues of the proximal humerus. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device consists of plates, screws, and instrumentation used for surgical fixation. These are physical implants and tools used during surgery.
- 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 screening.
IVD devices are used to perform tests on samples taken from the body, not to directly treat conditions within the body. This device is clearly designed for surgical treatment.
N/A
Intended Use / Indications for Use
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is a system of pre-contoured fracture plates, screws, and instrumentation for the repair of fractures of the proximal Humerus. The plates are designed to fit the natural anatomy of the proximal Humerus and include 3 sizes, different components for left and right Humeri, and plates designed to fit in different positions on the humerus. The proximal portions of the plates accept 3.5 mm locking screws for fixation of head, tuberosity, and shaft fragments to the plate. The distal portions of the plates accept 3.5 mm cortex compression screws which hold the plate construct to the humeral shaft.
EnHatch Orthopaedics Patient Optimized Humeral Fracture System Plates and Screws will be sold non-sterile. They are packaged and shipped in comprehensive trays that allow for secure transportation and on site sterilization. Products used for replenishment will be shipped, non-sterile, in a protective package (poly bag or tube).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
proximal 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)
Non-clinical mechanical testing was not necessary to determine substantial equivalence between the EnHatch Orthopaedics Patient Optimized Humeral Fracture System and the cited predicate devices.
For the plates, Finite Element Analysis was used to compare the strength of each EnHatch Plate with a Synthes LCP plate.
For the screws, a qualitative comparison to the Synthes predicate was done.
Results from these analyses provided with the 510(k) demonstrate that the EnHatch Orthopaedics Patient Optimized Humeral Fracture System are substantially equivalent to the identified predicate devices and will be safe for clinical use.
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.
Not Found
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
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K 112663 (1/3)
MAR 1 2 2012
SECTION 5: 510(K) SUMMARY
Summary of Safety and Effectiveness information
EnHatch Orthopaedics Patient Optimized Humeral Fracture System
Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92
-
- Device name
- Trade name: EnHatch Orthopaedics Patient Optimized Humeral Fracture System
Common name: Proximal Humeral Fracture Plate and Screws Classification Number/ Classification name/Product code:
Single/multiple component metallic bone fixation appliances and accessories are class II devices under 21 CFR 888.3030 (product code HRS) and are classified by the Orthopedic Devices Panel.
Smooth or threaded metallic bone fixation fasteners are class II devices under 21 CFR 888.3040 (product code HWC) and are classified by the Orthopedic Devices Panel.
2) Submitter
EnHatch Orthopaedics, LLC 160 Chubb Avenue, Suite 204 Lyndhurst. NJ 07071 Registration Number: See page 11
-
- Company contact
Michael Phipps Regulatory affairs 160 Chubb Avenue, Suite 204 Lyndhurst, NJ 07071 Phone: 201-377-9129 mphipps@EnHatch.com
- Company contact
4) Classification
| Device class: | Class II |
|---|---|
| Classification panel: | Orthopedic |
| Product code: | HRS, HWC |
-
- Legally Marketed Device to which Equivalence is Claimed:
- · Synthes LCP Proximal Humerus Plate: K011815
1
- · Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates: K082625
- · Synthes Small Fragment Dynamic Compression Locking (DCL) System: K000684
6) Device description
The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is a system of pre-contoured fracture plates, screws, and instrumentation for the repair of fractures of the proximal Humerus. The plates are designed to fit the natural anatomy of the proximal Humerus and include 3 sizes, different components for left and right Humeri, and plates designed to fit in different positions on the humerus. The proximal portions of the plates accept 3.5 mm locking screws for fixation of head, tuberosity, and shaft fragments to the plate. The distal portions of the plates accept 3.5 mm cortex compression screws which hold the plate construct to the humeral shaft.
EnHatch Orthopaedics Patient Optimized Humeral Fracture System Plates and Screws will be sold non-sterile. They are packaged and shipped in comprehensive trays that allow for secure transportation and on site sterilization. Products used for replenishment will be shipped, non-sterile, in a protective package (poly bag or tube).
7) Materials
- All EnHatch Patient Optimized Humeral Fracture System Plates and Screws are made . from 316L Stainless Steel per ASTM F138 Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical lmplants.
8) Indications for Use
- The EnHatch Orthopaedics Patient Optimized Humeral Fracture System is . indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.
9) Summary of technologies
- The technological characteristics (material, design, sizing, indications) of the . EnHatch Orthopaedics Proximal Humeral Fracture plates and screws are similar or identical to the cited predicate devices.
10) Summary of Non-clinical testing
Non-clinical mechanical testing was not necessary to determine substantial equivalence between the EnHatch Orthopaedics Patient Optimized Humeral Fracture System and the cited predicate devices.
- For the plates, Finite Element Analysis was used to compare the strength . of each EnHatch Plate with a Synthes LCP plate.
- For the screws, a qualitative comparison to the Synthes predicate was . done.
2
K1126.6 3(³/₃)
Results from these analyses provided with the 510(k) demonstrate that the EnHatch Orthopaedics Patient Optimized Humeral Fracture System are substantially equivalent to the identified predicate devices and will be safe for clinical use.
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 depiction of an eagle or bird-like figure with three wing-like shapes extending upwards and to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EnHatch Orthopaedics, LLC % Mr. Michael Phipps Chief Product Officer 160 Chubb Avenue, Suite 204 Lyndhurst, New Jersey 07071
MAR 1 2 2012
Re: K112663
Trade/Device Name: EnHatch Orthopaedics Patient Optimized Humeral Fracture System Regulation Number: 21 CFR 888.3030
Regulation Name: Single/multiple component metallic bone fixation appliances and accessories
Regulatory Class: Class II Product Code: HRS, HWC Dated: February 21, 2012
Received: February 21, 2012
Dear Mr. Phipps:
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 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
4
Page 2 - Mr. Michael Phipps
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 yours,
Mark A. Milikerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 4: INDICATION FOR USE STATEMENT
Indications for Use
510(k) Number (if known): K112663
EnHatch Orthopaedics Patient Optimized Humeral Fracture Device Name: System
Indications for Use
- The EnHatch Orthopaedics Patient Optimized Humeral Fracture System_is . indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal Humerus, particularly in osteopenic bone.
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 NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112663
510(k) Additional Information Response: EnHatch Orthopaedics Patient Optimized Humeral Fracture System