(266 days)
Not Found
No
The summary describes a physical implant device and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an implant used for the treatment of a medical condition (hyperpronated foot and stabilization of the subtalar joint), which clearly falls under the definition of a therapeutic device.
No
The device is an implant used for the treatment of hyperpronated foot and stabilization of the subtalar joint, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states the device is a physical implant made of PEEK and tantalum, designed to be surgically introduced into the sinus tarsi. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The PIT Stop implant is a physical implant designed to be surgically inserted into the foot to treat hyperpronation and stabilize the subtalar joint. It is a therapeutic device, not a diagnostic test performed on a sample.
- Lack of Diagnostic Activity: The description focuses on the mechanical function of the implant in blocking excessive pronation. There is no mention of analyzing biological samples or providing diagnostic information.
Therefore, the PIT Stop implant falls under the category of a surgical implant or orthopedic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes, insoles ... )
- Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instability
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The PIT'Stop® implant is a cannulated implant composed of two symmetrical and flattened sides, and small blades. The PIT'Stop® implant is designed to adequately maintain the filling of the sinus tarsi, and is made of PEEK, a material recognized for its mechanical and radiolucent properties. The PIT'Stop® implant is introduced into the axis of sinus tarsi, and its fixation is performed by anti-return flanges. The PIT'Stop implant should be removed: at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from 10mm to 17mm. Material: The PIT'Stop® implant is made of PEEK according to standard ASTM F2026 and include markers made of tantalum according to ASTM F560. Single use: The PIT'Stop® implant is designed for single use only. Sterilization: The PIT'Stop® implant is supplied sterile, using gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, subtalar joint, sinus tarsi
Indicated Patient Age Range
children, adolescents, adult
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)
Performance testing of the PIT'Stop® implant was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on PIT'Stop® implant. The results of the testing performed by the independent test laboratory indicate that the PIT'Stop® implant met the acceptance criteria.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
November 28, 2017 In2bones Sas % Norman Estrin Managing Partner Estrin Consulting Group LLC 3100 N. Leisure World Blvd., Apt. 121 Silver Spring, Maryland 20906
Re: K170688
Trade/Device Name: PIT'Stop® implant Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: October 17, 2017 Received: October 23, 2017
Dear Norman Estrin:
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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170688
Device Name
PIT'Stop® implant
Indications for Use (Describe)
The PIT Stop implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and medial displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes, insoles ... )
- Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instability
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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3
Image /page/3/Picture/1 description: The image shows the logo for IN2BONES. The logo is in a gray oval shape with a white curved line on the left side. The text "IN2BONES" is in white, with the "2" in orange.
For
| Sponsor identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | October 13th, 2017 |
| Contact person | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
3100 N. Leisure World Blvd.
Silver Spring, MD 20906
Phone: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Authorized Agent in
the United States | Norman F. Estrin, Ph.D.
Estrin Consulting Group LLC
3100 N. Leisure World Blvd.
Silver Spring, MD 20906
Phone: 240-994-9999
Email: estrin@yourFDAconsultant.com |
| Proprietary Name | PIT'Stop® implant |
| Common name | Subtalar implant |
| Device classification
regulation | 21 CFR 888. 3040: Smooth or threaded metallic bone
fixation screw or fastener
Class II |
| Device Product
Code and Panel | HWC: screw, fixation, bone
87 orthopedics |
| Device Description | The PIT'Stop® implant is a cannulated implant composed of
two symmetrical and flattened sides, and small blades.
The PIT'Stop® implant is designed to adequately maintain
the filling of the sinus tarsi, and is made of PEEK, a material
recognized for its mechanical and radiolucent properties.
The PIT'Stop® implant is introduced into the axis of sinus
tarsi, and its fixation is performed by anti-return flanges.
The PIT'Stop implant should be removed:
at the end of the growth when used in pediatric patients or by 12 months when used in adult patients or if pain occurs earlier Sizes: The PIT'Stop® implant is designed in 7 sizes, from
10mm to 17mm.
Material: The PIT'Stop® implant is made of PEEK according
to standard ASTM F2026 and include markers made of
tantalum according to ASTM F560.
Single use: The PIT'Stop® implant is designed for single use
only.
Sterilization: The PIT'Stop® implant is supplied sterile, using
gamma irradiation. |
| Predicate Devices | Newdeal KALIX® II Flat foot implant (K061765)
Solana Surgical, LLC, Gaitway Implant System (K122738)
In2Bones OS2®-VP varisation staple (K153770) |
| Indications for use: | The PIT'Stop® implant is indicated for use in the treatment
of the hyperpronated foot and stabilization of the subtalar
joint.
It is designed to block forward, downward and medial
displacement of the talus, thus allowing normal subtalar joint
motion but blocking excessive pronation and the resulting
sequela.
- Flat foot treatment in children and adolescents
- Congenital flat foot
- Non successful long term orthopaedic treatment (shoes,
insoles...) - Tarsal coalitions
- Painfully flat foot
- Supple deformity in posterior tibial tendon dysfunction
- Paralytic flat foot
- Subtalar instability |
4
5
| Comparison of the
indications for use
with the predicate
device: | The indications for use for the PIT'Stop® implant are identical to
the predicate devices Newdeal KALIX® II Flat foot implant
(K061765), and Solana Surgical, LLC, Gaitway Implant System
(K122738). |
|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of
Technological
characteristics and
Substantial
Equivalence
Summary: | The PIT'Stop® implant is similar to the predicate devices Newdeal
KALIX® II Flat foot implant (K061765) and Solana Surgical, LLC,
Gaitway Implant System (K122738) in intended use, design, sizes
and principles of operation, and is similar to the predicate device
OS2®-VP Varisation staple (K153770) in material. |
| Summary
Performance Data | Performance testing of the PIT'Stop® implant was assessed through
mechanical bench testing performed by an independent test
laboratory, animal and clinical testing being considered not
applicable.
Testing performed included static and dynamic compression tests
on PIT'Stop® implant. The results of the testing performed by the
independent test laboratory indicate that the PIT'Stop® implant met
the acceptance criteria. |
| CONCLUSION | Based on the comparison of indications for use and technological
characteristics and the results of the testing performed, the
PIT'Stop® implant is substantially equivalent to the predicate
devices identified in the 510(k) submission. |