(157 days)
Not Found
No
The 510(k) summary describes a mechanical plating system for bone fixation and does not mention any AI or ML components or functionalities. The performance studies are based on mechanical testing standards.
Yes
The device is indicated for the fixation of fractures and non-unions of various bones, which is a therapeutic intervention.
No
Explanation: The device is a Locked Plating System intended for fixation of fractures and non-unions, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states the system is comprised of plates, screws, and instruments, which are physical hardware components made of Titanium Alloy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "fixation of fractures and non-unions of various bones". This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is comprised of "plates, screws and instruments to facilitate the installation of the implants". These are physical implants and tools used in surgery.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
This device is clearly an orthopedic implant system used for surgical repair of bones, not for testing biological samples.
N/A
Intended Use / Indications for Use
Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.
Product codes
HRS, HWC
Device Description
The purpose of this submission is to request clearance for the new Pitkar Locked Plating System. The Pitkar Locked Plating System implants are designed to address fractures of the humerus, radius, ulna, femur, tibia, fibula, and clavicle. The system is comprised of plates, screws and instruments to facilitate the installation of the implants. The plates and screws are manufactured from Titanium Alloy per ASTM F136. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, radius, ulna, femur, tibia, fibula and clavicle
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 Tests:
The device performance of Pitkar Locked Plating System has been demonstrated against following applicable standards
- ASTM F 382
- ASTM F 384
- ASTM F 543
For Bone Plates as per ASTM F 382 & ASTM F 384
- Static Four Point Bend Test
- Dynamic Four Point Bend Test
For Bone Screws as per ASTM F 543
- Torsional Properties
- Driving Torque
- Pull-Out test
Biocompatibility:
Pitkar Locked Plating System devices are comprised of the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants. Therefore, the Pitkar Locked Plating System devices meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374, SYNTHES LCP Distal Tibia Plates - K013248, SYNTHES LCP Proximal Tibia Plate - K030597, SYNTHES LCP Distal Femur Plates - K062564, SYNTHES LCP Distal Humerus Plates - K033995, SYNTHES LCP Proximal Humerus Plates - K011815, SYNTHES Locking Distal Radius Plating System - K012114, SYNTHES LCP Clavicle Plate System - K073186
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
February 27, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar Head of Firm Plot No. EL 32, J Block, MIDC Bhosari Pune, 411026 India
Re: K192619
Trade/Device Name: Pitkar Locked Plating 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: September 15, 2019 Received: September 23, 2019
Dear Vivek Mangalwedhekar:
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.
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
1
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 (OS) 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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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)
Device Name Pitkar Locked Plating System
Indications for Use (Describe)
Pitkar Locked Plating System is indicated for fixation of fractures and non-unions of various bones including the humerus, radius, ulna, femur, tibia, fibula and clavicle, including in osteopenic bone.
| 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
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Pitkar Locked Plating System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| 1. Submitter: | S H Pitkar Orthotools Pvt Ltd.
Plot No. EL 32, J Block, MIDC Bhosari
Pune
Maharashtra 411026
India |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Vivek Mangalwedhekar
Head of Firm
Telephone: +912040706464
Fax: +912046768107 |
| Date: | 27-Feb-20 |
| 2. Device Name: | Pitkar Locked Plating System |
| Common or Usual Name: | Orthopedic Bone Plate
Orthopedic Bone Screw |
| Classification Name: | Plates, Fixation, Bone
Screws, Fixation, Bone |
| Product Code: | HRS- Single/multiple component metallic bone
fixation appliances and accessories (21 CFR
888.3030)
HWC -Smooth or threaded metallic bone
fixationfastener (21 CFR 888.3040) |
| Regulatory Class: | ll |
| 3. Primary Predicate Device(s): | CARE BRAND Locking Bone Plate and Screws
Osteosynthesis Plating System - K153374 |
| Other Predicate Devices : | SYNTHES LCP Distal Tibia Plates - K013248
SYNTHES LCP Proximal Tibia Plate - K030597
SYNTHES LCP Distal Femur Plates - K062564
SYNTHES LCP Distal Humerus Plates - K033995
SYNTHES LCP Proximal Humerus Plates -
K011815
SYNTHES Locking Distal Radius Plating System-
K012114
SYNTHES LCP Clavicle Plate System - K073186 |
| 4. Device Description: | The purpose of this submission is to request
clearance for the new Pitkar Locked Plating
System. The Pitkar Locked Plating System
implants are designed to address fractures of the
humerus, radius, ulna, femur, tibia, fibula, and
clavicle. The system is comprised of plates, screws
and instruments to facilitate the installation of the
implants. The plates and screws are manufactured
from Titanium Alloy per ASTM F136. Implants and
instruments will be provided in non-sterile
configuration and will require steam sterilization
prior to use. |
| 5. Indications for Use: | The Pitkar Locked Plating System is indicated for
fixation of fractures osteotomies and non-unions of
various bones including the humerus, radius, ulna femur, tibia, fibula, and clavicle, including
osteopenic bone. |
4
-
- Summary of Technological Characteristics and comparison to predicate device
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Summary of Technological Characteristics and comparison to predicate device
Design Features: The design features for the Pitkar Locked Plating System is similar to the Primary predicate system device- CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374
Materials & Chemical Compostion:The Pitkar Locked Plating System plates and screws are manufactured from Titanium Alloy (per ASTM F136). Implant grade titanium alloys are commonly used materials in orthopedic implants & instruments are manufactured from Standard Specification For Wrought Stainless Steels For Surgical Instruments (ASTM F899 -2012) similar to the Primary predicate system device- CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374
Sterilization: The implants and instruments are offered to the user in the non-sterile configuration. The non-sterile implants and instruments will be required to be steam sterilized by the user prior to use. The non- sterile packaging configuration is similar to the Primary predicate devices - CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374
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7. Summary of Performance Data (Nonclinical and/or Clinical)
Non-Clinical Tests:
The device performance of Pitkar Locked Plating System has been demonstrated against following applicable standards
- ASTM F 382 ●
- ASTM F 384 ●
- ASTM F 543 .
For Bone Plates as per ASTM F 382 & ASTM F 384
- Static Four Point Bend Test ●
- . Dynamic Four Point Bend Test
For Bone Screws as per ASTM F 543
- Torsional Properties ●
- . Driving Torque
- Pull-Out test ●
Biocompatibility:
Pitkar Locked Plating System devices are comprised of the same material and have the same manufacturing, body contact, and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants. Therefore, the Pitkar Locked Plating System devices meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
- Conclusion: From the data available, we can justify that the Pitkar Locked Plating System is safe as effective and perform as same indications for use as that of already marketed predicate devices identified in point 3 of 510(k) summary i.e Primary predicate devices CARE BRAND Locking Bone Plate and Screws Osteosynthesis Plating System - K153374
Hence Pitkar Locked Plating System can be considered safe and effective for inteded use.