(30 days)
No
The summary describes a system of plates, screws, and K-wires for bone fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on sterilization and packaging, not algorithmic performance.
Yes
The device is indicated for use in hand and forearm fractures and arthrodeses, and for conditions such as osteoarthritis and post-traumatic arthritis. These uses are directly related to treating or mitigating a disease or injury, thus classifying it as a therapeutic device.
No
Explanation: The device is described as a plating, screw, and K-wire system for internal fixation of hand, wrist, and/or forearm fractures and arthrodeses. It is an implant used for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "plating, screw, and K-wire system for internal fixation," which are physical hardware components. The submission focuses on the sterilization and packaging of these hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a system for internal fixation of bone fractures and arthrodeses in the hand, wrist, and forearm. This is a surgical implant used in vivo (within the body) to provide structural support and stability to bones.
- Device Description: The device is described as a plating, screw, and K-wire system made of titanium and stainless steel. These are physical implants designed to be surgically inserted into the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. The description of the APTUS system does not involve any testing of biological samples.
The APTUS® Titanium Fixation System is a surgical implant, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group:
· Management of the fractures of the distal, middle and proximal phalanges and metacarpals
· Management of all types of transversal fractures, fractures near joints with or without joint involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
· DIP and PIP arthrodeses
APTUS® Radius 2.5 group:
· Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
· Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as quide pins for insertion of other implants.
APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Hand group:
- Management of the fractures of the distal, middle and proximal phalanges and metacarpals
· Management of all types of transversal fractures, fractures near joints with or without joint involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
· DIP and PIP arthrodeses
APTUS® Radius 2.5 group:
· Management via radio volar approach of extra-articular extension fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
· Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.
Product codes
HRS, HWC, HTY
Device Description
The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws.
Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters.
This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
All subject device screws are manufactured from titanium alloy conforming to ASTM F136.
All subject device K-wires are manufactured from stainless steel conforming to ASTM F138.
All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand, wrist, forearm, distal phalanges, middle phalanges, proximal phalanges, metacarpals, DIP, PIP, radius, ulna, carpal bones (hamate, capitate, lunate, triquetrum)
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)
An analysis of the risk documentation and an engineering analysis was performed. These determined that the original testing of the sterilization process, previously cleared in the reference device submission under K191848, and the subsequent device performance is not adversely affected by the modifications to the results of the analysis demonstrated the modified sterility and packaging are substantially equivalent to the predicate devices.
Non-clinical testing data referenced and relied won to demonstrate included: sterilization validation according to ISO 1137-1, ISO 11137-2, and ISO 11137-3. Sterile barrier shelf life testing according to ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M.
The subject device is manufactured from the same matering processes as their associated predicate device. There is no change to the type and duration of tissue contact for the subject device from the associated predicate device. The device modification, changing the sterilization method, was previously cleared under the reference device submission. Therefore, the device modification, that is the subject of this submission, is not expected to impact the biological response.
Clinical data is not provided in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K051567, K090983, K092038, K102537, K103332, K142906, K172170, K192297, K193554
Reference Device(s)
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
August 18, 2023
Image /page/0/Picture/1 description: The image contains 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.
Medartis AG % Chelsea Kozior Regulatory Affairs Manager Medartis Inc. 1195 Polk Drive Warsaw, Indiana 46582
Re: K232144
Trade/Device Name: Sterile Products of the APTUS 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 Dated: July 17, 2023 Received: July 19, 2023
Dear Chelsea Kozior:
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
1
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 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 (QS) 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 -S
Shumaya Ali, M.P.H. 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
2
Indications for Use
510(k) Number (if known) K232144
Device Name
Sterile Products of the APTUS System
Indications for Use (Describe)
APTUS® Titanium Fixation System
The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures and arthrodeses. APTUS® Hand group:
- · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
- · Management of all types of transversal fractures, spiral fractures near joints with or without joint
- involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
- · DIP and PIP arthrodeses
- APTUS® Radius 2.5 group:
- · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
- Management via dorsal approach of ractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as guide pins for insertion of other implants.
APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group:
- · Management of the fractures of the distal, middle and proximal phalanges and metacarpals
- · Management of all types of transversal fractures, fractures near joints with or without joint
- involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
- DIP and PIP arthrodeses
- APTUS® Radius 2.5 group:
- · Management via radio volar approach of extra-aticular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
- Management via dorsal approach of ractures that cannot be adequately reduced via volar approach.
procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS® Wrist 2.5 System
3
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures and arthrodeses.
APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.
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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4
510(k) Summary
Prepared on: 2023-08-07
Contact Details
| Applicant Name | Medartis AG | ||
|---|---|---|---|
| Applicant Address | Hochbergerstrasse 60E Basel 4057 Switzerland | ||
| Applicant Contact Telephone | +41 61 6333434 | ||
| Applicant Contact | Ms. Claudia De Santis | ||
| Applicant Contact Email | claudia.desantis@medartis.com | ||
| Correspondent Name | Medartis Inc. | ||
| Correspondent Address | 1195 Polk Drive Warsaw IN 46582 United States | ||
| Correspondent Contact Telephone | 610-731-8650 | ||
| Correspondent Contact | Ms. Chelsea Kozior | ||
| Correspondent Contact Email | chelsea.kozior@medartis.com | ||
| Device Name | 21 CFR 807.92(a)(2) | ||
| Device Trade Name | Sterile Products of the APTUS System | ||
| Common Name | Plate, Fixation, Bone (Primary) / Screw, Fixation, Bone / Pin, Fixation, Smooth | ||
| Classification Name | Single/multiple component metallic bone fixation appliances and accessories (Primary) | ||
| Smooth or threaded metallic bone fixation fastener | |||
| Regulation Number | 888.3030 (Primary) / 888.3040 | ||
| Product Code | HRS (Primary) / HWC / HTY | ||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K051567 | APTUS® Titanium Fixation System | HRS | |
| K090983 | APTUS® 2.0/2.3 Four Corner Fusion Plates | HRS | |
| K092038 | APTUS® K-Wire System | HTY | |
| K102537 | APTUS® 1.5 TriLock | HRS | |
| K103332 | APTUS® Ulna System | HRS |
5
| K142906 | APTUS ® Wrist 2.5 System | HRS |
|---|---|---|
| --------- | -------------------------- | ----- |
| K172170 | APTUS ® Wrist 2.5 System | HRS |
|---|---|---|
| --------- | -------------------------- | ----- |
| K192297 | APTUS ® Wrist Arthrodesis System | HRS |
|---|---|---|
| --------- | ---------------------------------- | ----- |
| K193554 | APTUS ® Forearm Shaft Plates | HRS |
|---|---|---|
| --------- | ------------------------------ | ----- |
| K191848 | APTUS ® Wrist Spanning Plates 2.5 (Reference Device) | HRS |
|---|---|---|
| --------- | ------------------------------------------------------ | ----- |
Device Description Summary
21 CFR 807.92(a)(4)
The Sterile Products of the APTUS System is a plating, screw, and K-wire system for internal fixation of the hand, wrist, and/ or forearm. All plates have anatomical designs that are appropriate to their intended use. The subject device plates includes crew holes designed to accommodate appropriately sized bone screws.
Sterile Products of the APTUS System plate, screw, and K-wire system are the previously cleared predicate and additional predicate devices. The overal dimens of the subject device plates have the same lengths, widths, and thicknesses as the previously cleared predicate and additional predicate device screws have the same design as the previously cleared Medartis APTUS Screws under K051567, K103332, and K142906. These include both locking (cortical) screws. The subject device K-wires have design as the previously cleared APTUS K-Wires System under K092038. The K-wires are provided with a diameter of 1.2, 1.6, or 1.8 mm. All have a length of 150 mm. Single-ended trocar points are provided in 1.2 mm and 1.6 mm diameters, and single-ended bayonet (lancet) points are provided at all 3 diameters.
This submission includes all plates screws, and K-wires that have been previously cleared under the predicate devices by Medartis AG, however, they will be provided in a sterile condition.
All subject device plates are manufactured from unalloyed titanium conforming to ASTM F67.
All subject device screws are manufactured from titanium alloy conforming to ASTM F136.
All subject device K-wires are manufactured from stainless steel conforming to ASTM F138.
All subject devices are associated with the predicate device and/or an additional predicate device mentioned in the predicates and product list sections.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The APTUS® Titanium Fixation System
The APTUS® Titanium Fixation System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses. APTUS® Hand group:
· Management of the fractures of the distal, middle and proximal phalanges and metacarpals
· Management of all types of transversal fractures, fractures near joints with or without joint involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
· DIP and PIP arthrodeses
APTUS® Radius 2.5 group:
· Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
· Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® 2.0/2.3 Four Corner Fusion Plate
The APTUS® 2.0/2.3 Four Corner Fusion Plate, an addition to the APTUS® Titanium Fixation System, is designed specifically for fusion of carpal bones including: hamate, capitate, lunate, triquetrum and is for use in patients suffering pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with locking and non-locking screws that fix the plate to the carpal bones of the hand.
APTUS® K-Wire System
The APTUS® K-Wire System is intended for use in fixation of bone reconstruction, and as quide pins for insertion of other implants.
6
APTUS® 1.5 TriLock
The APTUS® 1.5 TriLock is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Hand group:
- Management of the fractures of the distal, middle and proximal phalanges and metacarpals
· Management of all types of transversal fractures, fractures near joints with or without joint involvement, shaft fractures, comminuted fractures, dislocation fractures, avulsion fractures
· DIP and PIP arthrodeses
APTUS® Radius 2.5 group:
· Management via radio volar approach of extra-articular extension fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
· Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.
APTUS® Ulna Plates
APTUS® Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.
APTUS® Wrist 2.5 System
APTUS® Wrist 2.5 System is indicated for use in hand and forearm fractures, osteotomies and arthrodeses.
APTUS® Wrist Arthrodesis Plates APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
APTUS® Forearm Shaft Plates
APTUS® Forearm Shaft Plates are indicated for management of fractures and osteotomies of the radius and ulna shaft.
Indications for Use Comparison
The subject device has the same intended use and the same or similar Indications for Use as the predicate cleared under K051567 or associated additional predicate device cleared under K090983, K102537, K103332, K142906, K172170, K193554,
Technological Comparison
The subject device has the same technological characteristics as the predicate and/or the associated additional predicate devices. The subject and the predicate devices are all manufactured from the same materials (Unalloyed titanium, ASTM F67, grade 4, Ti-6Al-4 V alloy, ASTM F136; and stainless steel, ASTMF138). The subject and predicate devices share the subject device has modified packaged to be provided sterile to the end user. The subject device also has modification
process to be provided sterile to the end user. The device of this submission, previously cleared under the reference device submission, do not raise any new questions of safety or effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Performance Data
An analysis of the risk documentation and an engineering analysis was performed. These determined that the original testing of the sterilization process, previously cleared in the reference device submission under K191848, and the subsequent device performance is not adversely affected by the modifications to the results of the analysis demonstrated the modified sterility and packaging are substantially equivalent to the predicate devices.
Nor-clinical testing data referenced and relied won to demonstrate included: sterilization validation according to ISO 1137-1, ISO 11137-2, and ISO 11137-3. Sterile barrier shelf life testing according to ISO 11607-2, ASTM F1980, ASTM D4332, ASTM D4169, ASTM F2096, DIN EN 868-5, and ASTM F88/F88M.
The subject device is manufactured from the same matering processes as their associated predicate device. There is no change to the type and duration of tissue contact for the subject device from the associated predicate device. The device modification, changing the sterilization method, was previously cleared under the reference device submission. Therefore, the device modification, that is the subject of this submission, is not expected to impact the biological response.
Clinical data is not provided in this submission.
Conclusion
In summary, the Sterile Products of the APTUS System has the following similarities to the predicate device and additional predicate devices :
7
· has the same intended use and the same or similar indications for use ,
- · uses the same operating principle,
- · incorporates the same basic design,
- · incorporates the same materials, and
• has modified packaging so the device can be provided to the end user in a sterile condition.
The device modifications do not raise any new questions of the subject device. Therefore, the Sterile Products of the APTUS System is substantially equivalent to the predicate devices with respect to intended use, operating principles, and technical characteristics.