(200 days)
K 970748
K 970748
No
The description mentions software that assists the physician by receiving inputs and producing outputs recommending adjustments, but it does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a learning process or the use of training/test data sets, which are typical indicators of AI/ML. The software appears to be based on calculations or algorithms derived from physician inputs, similar to the predicate device (Taylor Spatial Frame), which is a mechanical/software system for deformity correction.
Yes
The device is indicated for various treatments such as fracture fixation, limb lengthening, and correction of deformities, all of which are therapeutic interventions.
No
The device is described as assisting "the physician in performing precise deformity or fracture reduction" and producing "outputs recommending adjustments to the fixator that define a correction path." This indicates it is used for treatment planning and guidance, not for diagnosing a condition.
No
The device description explicitly states that the system "includes a web based software... and should always be used with hardware." It also mentions "implantable components" and "external skeletal fixation devices" in the performance studies, indicating the presence of physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Pitkar Sixafix System Function: The Pitkar Sixafix System is an external skeletal fixation system used for orthopedic procedures like fracture fixation, limb lengthening, and deformity correction. It involves implantable hardware and software to assist the physician in planning and performing these procedures directly on the patient's body.
- Lack of Specimen Analysis: The description of the Pitkar Sixafix System does not mention any analysis of specimens taken from the human body. Its function is entirely focused on the mechanical manipulation and correction of bones and soft tissues.
Therefore, based on the provided information, the Pitkar Sixafix System clearly falls outside the definition and scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.
-
- Open and closed fracture fixation
-
- Pseudoarthrosis or non-union of long bones
-
- Limb lengthening by epiphyseal or metaphyseal distraction
-
- Correction of bony or soft tissue deformities
-
- Correction of segmental or nonsegmental bony or soft tissue defects
-
- Post-Traumatic joint contracture which has resulted in loss of range of motion
Product codes
KTT, OSN
Device Description
The purpose of this submission is to request clearance for the new Pitkar Sixafix System. The Pitkar Sixafix System includes a web based software that is designed to assist the physician in performing precise deformity or fracture reduction and should always be used with hardware. The Sixafix System software receives inputs from measurements taken by the physician and produces outputs recommending adjustments to the fixator that define a correction path for the deformity. To guide the surgeon, detailed information is provided in Software manual. The implantable components are manufactured from Stainless Steel per ASTM F138. The system 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
Not Found
Indicated Patient Age Range
adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.
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:
-
- Software Verification and Validation per FDA's guidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
-
- ASTM F1541-02 "Standard Specification and Test Methods for External Skeletal Fixation Devices"
- Four point bend test
- Cantiliver bent test A-P plane
- Cantiliver bent test L-M plane
- Axial load test
- Torsion test
- Fatique test
Biocompatibility: The Pitkar Sixafix System is 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 Sixafix System 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)
Smith & Nephew Inc.- Taylor Spatial Frame -K 970748
Reference Device(s)
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
October 6, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
S H Pitkar Orthotools Pvt Ltd. Vivek Mangalwedhekar Head of Firm Plot No. EL 32, J Block, MIDC Bhosari Pune, Maharashtra 411026 India
Re: K200728
Trade/Device Name: Pitkar Sixafix System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: KTT, OSN Dated: September 1, 2020 Received: September 8, 2020
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 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
1
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 medical devices and radiation-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,
Ting Song, Ph.D., R.A.C. 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Pitkar Sixafix System
Indications for Use (Describe)
Pitkar Sixafix System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which the growth of plates have fused or will not be the crossed with the hardware.
-
- Open and closed fracture fixation
-
- Pseudoarthrosis or non-union of long bones
-
- Limb lengthening by epiphyseal or metaphyseal distraction
-
- Correction of bony or soft tissue deformities
-
- Correction of segmental or nonsegmental bony or soft tissue defects
-
- Post-Traumatic joint contracture which has resulted in loss of range of motion
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------- |
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Expiration Date: 06/30/2020
See PRA Statement below.
3
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 Sixafix 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: | 05-October-2020 |
| 2. Device Name: | Pitkar Sixafix System |
| Common or Usual Name: | Pitkar Sixafix System |
| Classification Name: | Single/multiple component metallic bone fixation
appliances and accessories (21 CFR 888.3030) |
| Product Code: | KTT, OSN |
| Regulatory Class: | II |
| 3. Predicate Device(s): | Smith & Nephew Inc.- Taylor Spatial Frame -K 970748 |
| 4. Device Description: | The purpose of this submission is to request clearance for
the new Pitkar Sixafix System. The Pitkar Sixafix System
includes a web based software that is designed to assist
the physician in performing precise deformity or fracture
reduction and should always be used with hardware.
The Sixafix System software receives inputs from
measurements taken by the physician and produces
outputs recommending adjustments to the fixator that
define a correction path for the deformity. To guide the
surgeon, detailed information is provided in Software
manual.
The implantable components are manufactured from
Stainless Steel per ASTM F138. The system will be
provided in non-sterile configuration and will require steam
sterilization prior to use. |
| 5. Indications for Use: | The Pitkar Sixafix System is indicated for the following
treatments in adults, and in both children (3-12) and
adolescents (12-21) in which the growth of plates have
fused or will not be the crossed with the hardware |
- . Open and closed fracture fixation
- Pseudoarthrosis or non-union of long bones
4
- Limb lengthening by epiphyseal or metaphyseal ● distraction
- Correction of bony or soft tissue deformities .
- Correction of segmental or nonseqmental bony or . soft tissue defects
- . Post-Traumatic joint contracture which has resulted in loss of range of motion
-
- Summary of Technological The rationale for substantial equivalence is based on consideration of the following characteristics: Characteristics:
Design Features: The design features for the Pitkar Sixafix System is similar to predicate devices namely Smith & Nephew Inc.- Taylor Spatial Frame -K 970748
Materials & Chemical Composition: The Pitkar Sixafix System implants are single use and manufactured from implant grade stainless steels (per ASTM F138) which is commonly used materials in orthopedic implants. Appliances are single use and manufactured from Aluminium. Instruments are reusable and manufactured from Standard Specification For Wrought Stainless Steels For Surgical Instruments (ASTM F899 -2012) similar to predicate devices namely Smith & Nephew Inc.- Taylor Spatial Frame -K 970748
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 predicate device Smith & Nephew Inc.- Taylor Spatial Frame -K 970748
-
- Summary of Performance Non-Clinical Tests: Data:
(Nonclinical and/or Clinical)
- Summary of Performance Non-Clinical Tests: Data:
-
- Software Verification and Validation per FDA's quidance document titled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
-
- ASTM F1541-02 "Standard Specification and Test Methods for External Skeletal Fixation Devices"
- Four point bend test .
- Cantiliver bent test A-P plane ●
- Cantiliver bent test L-M plane ●
- Axial load test ●
- Torsion test ●
- . Fatique test
Biocompatibility
The Pitkar Sixafix System is comprised of the same material and have the same manufacturing, body contact,
5
and sterilization properties as other commercially available devices and materials with a long history of clinical use in orthopedic implants. Therefore, the Pitkar Sixafix System meets the ISO 10993-1 standard requirements for biocompatibility and no further characterization testing is required.
- Conclusion: The comparisons of indications for use and technological characteristics with the predicate device and the performance data demonstrate that the Pitkar SixaFix System is substantially equivalent to the legally marketed predicate devices identified in point 3 of 510(k) summary i.e Smith & Nephew Inc.- Taylor Spatial Frame -K 970748