(58 days)
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
The subject devices are metallic bone staples to be marketed under the name 'Staple All-in-One'' as part of the APTUS® Foot System. The subject device staples are provided in designs to address clinical needs depending on the size and surface of the bone to be fused, and include two sizes and two angulations (or offsets). Each subject device is provided as a set, comprising the staple and a set of attached instruments. The instruments consist of two drill guide, and a positioning instrument. The drills and drill guide are snapped off of the set prior to use of the staple. The positioning instrument is snapped off of the staple after implantation. The subject device staples and instruments are made of stainless steel conforming to ISO 5832-1 and ASTM F139.
The provided text is a 510(k) summary for the Medartis AG APTUS® Foot System, which is a medical device for bone fixation. It describes the device, its intended use, and how it was deemed substantially equivalent to a predicate device.
It does NOT contain information about any AI/ML-driven device or study results proving acceptance criteria for such a device. The document explicitly states:
"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18: and comparative mechanical testing according to ASTM F564. Clinical data were not provided in this submission."
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text is for a traditional medical device (a bone fixation staple) and does not involve AI or clinical performance studies for its clearance.
To answer your question accurately, I would need a document that describes the clinical performance evaluation of an AI/ML-driven medical device.
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Auqust 16, 2019
Medartis AG % Kevin Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K191636
Trade/Device Name: APTUS Foot System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: June 18, 2019 Received: June 19, 2019
Dear Kevin Thomas:
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
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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,
Vesa Vuniqi Acting Assistant Director DHT6A2: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
APTUS® Foot System
Indications for Use (Describe)
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
| 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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510(k) Summary
Medartis AG
APTUS® Foot System
June 18, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone: +41 61 633 34 34Fax: +41 61 633 34 00 |
|---|---|
| Official Contact | Andrea SchweizerHead of Quality Management |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130 |
|---|---|
| Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Device Name | APTUS® Foot System |
|---|---|
| Common Name | Staple, fixation, bone |
| Regulation Number | 21 CFR 888.3030 |
| Regulation Name | Single/multiple component metallic bone fixation appliancesand accessories |
| Regulatory Class | Class II |
| Product Code | JDR |
| Classification Panel | Orthopedic Products Panel |
| Reviewing Division | Division of Health Technology 6 C(Restorative, Repair and Trauma Devices) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K991566, Solustaple®, New Deal S.A.
Reference Device K142581, APTUS® Foot System, Medartis AG.
INDICATIONS FOR USE
The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges.
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SUBJECT DEVICE DESCRIPTION
The subject devices are metallic bone staples to be marketed under the name 'Staple All-in-One'' as part of the APTUS® Foot System. The subject device staples are provided in designs to address clinical needs depending on the size and surface of the bone to be fused, and include two sizes and two angulations (or offsets). Each subject device is provided as a set, comprising the staple and a set of attached instruments. The instruments consist of two drill guide, and a positioning instrument. The drills and drill guide are snapped off of the set prior to use of the staple. The positioning instrument is snapped off of the staple after implantation. The subject device staples and instruments are made of stainless steel conforming to ISO 5832-1 and ASTM F139.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: sterilization validation according to ISO 11137-1, and ISO 11137-3; bacterial endotoxin testing according to ANSI AAMI ST72; sterile barrier shelf life testing according to ISO 11607-1, ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M; biocompatibility testing according to ISO 10993-12, ISO 10993-15, and ISO 10993-18: and comparative mechanical testing according to ASTM F564. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICE
The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference device listed above. Provided at the end of this summary is a table comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device, and the reference device.
The primary predicate device K991566 is for support of substantial equivalence based on a similar Indications for Use Statement (IFUS), similar device design and materials, and performance in side-byside mechanical testing. The reference device K142581 is for the IFUS, which is identical to the subject device; the subject device is an extension to the system cleared in K142581 and K091479.
The subject device, the primary predicate device, and the reference predicate device have the same intended use for internal fixation of the foot. The Indications for Use Statement (IFUS) is identical for the subject device and the reference device K142581. The IFUS for the primary predicate device K991566 is similar to the IFUS for the subject device. The primary predicate device K991566 includes only indications for Akin type osteotomies; this difference does not impact substantial equivalence because both the subject devices cleared in K991566 are intended for fixation of this type of osteotomy.
The subject device and the primary predicate device have technological characteristics and are fabricated from similar stainless steel materials. The subject device and the primary predicate device have similar design characteristics, including leg length, interaxis distance, offset, and thickness/diameter.
The stainless steel material of the subject device in its final finished form is similar to the stainless steel used in Medartis K-wires cleared in K092038 in formulation and processing.
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The subject device is provided as a sterile, single-use set, comprising the staple and a set of attached instruments (two drills, drill guide, and positioning instrument). The primary predicate device staples are provided sterile or non-sterile, and a set of corresponding reusable instruments are provided separately. The sterilization method for the primary predicate device is not stated in the 510(k) Summary for K991566. These differences do not impact the safety or effectiveness of the subject device as compared to the primary predicate device because all implants and instruments will be sterile when used clinically.
Mechanical testing according to ASTM F564 demonstrated the subject device to be substantially equivalent to the primary predicate device.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and the primary predicate device are made of the same material, and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the primary predicate device K991566 and the reference device K142581.
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able of Substantial Equivalence
| Comparison | Subject Device | Primary Predicate Device | Reference Device |
|---|---|---|---|
| Indications for Use Statement | APTUS® Foot SystemMedartis AGThe APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. | K991566Solustaple®New Deal S.A.The SOLUSTAPLE® is indicated for: Akin type osteotomy. | K142581APTUS® Foot SystemMedartis AGThe APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. |
| Product Code | JDR | JDR | HRS |
| Intended Use | Internal fixation of the bones of foot | Internal fixation of the bones of foot | Internal fixation of the bones of foot |
| Reason for Predicate | Not applicable | Similar staple design;Similar staple material;Comparison in mechanical testing | Identical IFUS |
| Device Designs | Anatomical plate designs for MTP and TMT fusion | ||
| Dimensions | Interaxis distance (between long axis of staple legs):8 mm, 10 mmOffset: 0°, 26°Leg length: 10 mm | Interaxis distance (between long axis of staple legs):8 mm, 10 mmOffset: 0°, 26°Leg length: 10 mm(From product labeling, not stated in 510(k) Summary) | Plates 1.6 mm to 2.0 mmScrew diameters 2.0 mm, 2.8 mm, 3.5 mmScrew lengths 10 to 13 mm (2.0 Ø);8 to 45 mm (2.8 Ø); 30 to 40 mm (3.5 Ø) |
| Thickness | 1 mm | 1 mm (diameter)(From product labeling, not stated in 510(k) Summary) | |
| Material | Stainless steel, ISO 5832-1, ASTM F139 | Stainless steel, ISO 5832-1, ASTM F138,ASTM F139(From product labeling, not stated in 510(k) Summary) | Plates: Unalloyed titanium, ASTM F67Screws: Ti-6Al-4V alloy, ASTM F136 |
| How Provided | |||
| Sterility | Provided sterile | Provided sterile or nonsterile(From product labeling, not stated in 510(k) Summary) | Provided non-sterile |
| Sterilization | Ionizing radiation (x-ray) | Not stated in 510(k) Summary | End-user to sterilize by moist heat |
| Usage | Single-patient, single-use | Single-patient, single-use(Not stated in 510(k) Summary) | Single-patient, single-use(Not stated in 510(k) Summary) |
§ 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.