(89 days)
No
The device description and performance studies focus on the mechanical properties and function of a physical suture anchor and associated tools, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for the reattachment of soft tissue to bone, which is a therapeutic intervention.
No
Explanation: The device is an all-suture anchor intended for reattaching soft tissue to bone, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components including an all-suture anchor, braided polyester and UHMWPE sutures, needles, a disposable insertion tool with a handle and deployment knob, and associated drills and guides. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the reattachment of soft tissue to bone." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a physical implant (suture anchor) and associated tools for surgical insertion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used for mechanical repair within the body.
N/A
Intended Use / Indications for Use
O-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- · Medial or lateral instability repairs/reconstructions
- · Achilles tendon repairs/reconstructions
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
Q-FIX with Needles is an all-suture anchor that consists of a fixation device intended to provide the reattachment of tissue to bone. The 1.8 mm implant is manufactured from braided polyester with ultra high molecular weightpolyethylene (UHMWPE) sutures with needles and is pre-loaded into a disposable tool designed to facilitate direct insertion into a pre-drilled bone hole. The device includes a handle and a deployment knob used to deploy one soft anchor implant into the joint spaceand a suture with needles compartment with a release handle.
Q-FIX with Needles includes two versions,
- Q-FIX with Needles, #0 SUTURE includes an all-sutureanchor loaded with . a #1 hot stretched tension suture and 2 #0 repair sutures
- . Q-FIX with Needles, MINITAPE includes an all-suture anchor loaded with a #1 hot stretched tension suture and 1 MINITAPE repairsuture
In addition, the Drill for Q-FIX with Needles, 2.2mm and Extremities Guide, Universal, are used to prepare the bone to insert the anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot and Ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 - Non-Clinical: For the non-clinical performance testing, both Q-FIX with Needles SKUs have been assessed for the following functional tests: Insertion and deployment (With the use of the Extremities Guide, Universal and the Drill for Q-FIX with Needles), Suture slide, Fixation, Cyclic UTS and displacement, Needle attachment strength, Knot tensile strength. For the non-clinical performance testing, the Drill for Q-FIX with Needles has been assessed for the following functional tests: Force and torque to drill, Torque to fail. Q-FIX with Needles devices met performance specifications for insertion strength, fixation, cyclic loading, UTS. Therefore, Q-FIX with Needles is equivalent to its predicate devices.
Performance Testing - Pre-Clinical: There was no pre-clinical testing required for the subject device.
Performance Testing - Animal: There was no animal testing required for the subject device.
Performance Testing - Clinical: There are no clinical studies performed on the subject device.
All testing demonstrates that the subject devices perform as intended and have acceptable performance when used in accordance with the labeling.
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.
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
Image /page/0/Picture/0 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 9, 2023
Smith & Nephew Inc. Pragnya Bakka Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810
Re: K231376
Trade/Device Name: O-FIX With Needles Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 8, 2023 Received: May 12, 2023
Dear Pragnya Bakka:
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.
1
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 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.
Jesse Muir -S
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231376
Device Name Q-FIX() with Needles
Indications for Use (Describe)
O-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- · Medial or lateral instability repairs/reconstructions
- Achilles tendon repairs/reconstructions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
1 GENERAL INFORMATION
| Submitter Name | Smith & Nephew, Inc. |
|---|---|
| Address | 150 Minuteman Road, Andover, |
| MA 01810, USA | |
| Contact Person | Pragnya Bakka |
| Senior Regulatory Affairs Specialist | |
| Date Prepared | 11 May 2023 |
| DEVICE NAME(S) | |
| Proprietary Name | Q-FIX ◊ with Needles |
| Common Name | Q-FIX ◊ with Needles, #0 SUTURE |
| Q-FIX ◊ with Needle, MINITAPE | |
| Q-FIX ◊ All-Suture Anchor with Needles. | |
| Classification Name | Smooth or threaded metallic bone fixation fastener |
| Device Class | Class II |
| Product Code | MBI |
| CFR Section | 21 CFR 888.3040 |
3 PREDICATE DEVICE(S)
2
| Primary Predicate | Q-FIX ® Suture Anchor (K172165) |
|---|---|
| Secondary Predicate Device | RAPTORMITE 3.0 PK Suture Anchor (K071586) |
| Reference Device | Bioraptor Knotless Suture Anchor (K093428) |
4
SUBJECT DEVICE (s) DESCRIPTION 4
Q-FIX with Needles is an all-suture anchor that consists of a fixation device intended to provide the reattachment of tissue to bone. The 1.8 mm implant is manufactured from braided polyester with ultra high molecular weightpolyethylene (UHMWPE) sutures with needles and is pre-loaded into a disposable tool designed to facilitate direct insertion into a pre-drilled bone hole. The device includes a handle and a deployment knob used to deploy one soft anchor implant into the joint spaceand a suture with needles compartment with a release handle.
Image /page/4/Figure/2 description: The image shows a medical device with several labeled parts. The front of the device has a thin, metallic "Implant" that is shielded inside a driver tube. Moving towards the back, the device has a "Housing nose", "Housing door", "Housing handle", and "Housing body". The back portion of the device has "Handle halves" and a "Deployment knob".
Figure 1 Components of Q-FIX with Needles
Image /page/4/Figure/4 description: This image shows two different surgical sutures. On the left is a Q-FIX WITH NEEDLES, MINITAPE, which is loaded with 1x MINITAPE with 2 needles and size #1 tensioning suture. On the right is a Q-FIX WITH NEEDLES, #0 Sutures, which is loaded with 2X #0 ULTRABRAID with 4 needles and size #1 tensioning suture. Both sutures are attached to a small block.
Figure 2 Q-FIX with Needles (MINITAPE), Q-FIX with Needles (#0 SUTURE)
5
Image /page/5/Picture/0 description: The image shows a close-up of a braided rope. The rope is primarily white with light blue accents. The braiding pattern is tight and consistent, creating a textured surface. The background is a dark, neutral color, which helps to highlight the rope's details.
Figure 3 Q-Fix Anchor(1.8mm)
Q-FIX with Needles includes two versions,
- Q-FIX with Needles, #0 SUTURE includes an all-sutureanchor loaded with . a #1 hot stretched tension suture and 2 #0 repair sutures
- . Q-FIX with Needles, MINITAPE includes an all-suture anchor loaded with a #1 hot stretched tension suture and 1 MINITAPE repairsuture
In addition, the Drill for Q-FIX with Needles, 2.2mm and Extremities Guide, Universal, are used to prepare the bone to insert the anchor.
6
Image /page/6/Figure/0 description: The image shows three different medical tools. The first tool is the Q-FIX with Needles, #0 SUTURE, which includes #0 sutures with needles and #1 suture with no needle. The second tool is the Q-FIX with Needles, MINITAPE, which includes Minitape with needles and #1 suture with no needle. The third tool is a drill for Q-FIX with Needles.
Table 1 Q-FIX with Needles Variants, accessories- Pictorial representation
7
Image /page/7/Figure/0 description: The image shows a medical device called the "Extremities Guide, Universal". The device is made of metal and has a long, thin shape with a curved end. The device is designed to be used to guide surgical instruments during orthopedic procedures. The device has a handle that is easy to grip and a tip that is designed to fit into small spaces.
5 INTENDED USE/INDICATIONS FOR USE
5.1 Intended use:
Q-FIX with Needles is intended for use for the reattachment of soft tissue to bone.
5.2 Indications for use:
Q-FIX with Needles use is only intended for the reattachment of soft tissue to bone for the following indications:
Foot and Ankle
- · Medial or lateral instability repairs/reconstructions
- · Achilles tendon repairs/reconstructions
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 6 PREDICATE DEVICE(S)
See Table 2 below for a summary of the comparison of the technological features between subject and predicate devices.
8
| | Q-FIX with Needles
(Subject Device) | Q-Fix Suture Anchor (1.8mm
Q-FIX Mini,
1.8 Q-FIX
2.8 Q-FIX (Primary
Predicate)(K172165) | Raptormite 3.0 PK
Suture Anchor
(Secondary
Predicate Device)
(K071586) | Smith & Nephew Knotless
Instability Anchor or
Bioraptor Knotless Suture
Anchor
(Reference Device)
(K093428) | |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | Reattachment of soft tissue to
bone | Same | Same | Same | |
| Indications for
Use | Q-FIX with Needles use is only
intended for the reattachment of
soft tissue to bone for the
following indications:
Foot and Ankle
• Medial or lateral instability
repairs/ reconstructions
• Achilles tendon repairs/
reconstructions | The Q-Fix Suture Anchor is intended
to be used for soft tissue to bone
fixation for:
Shoulder : Bankart lesion repair,
SLAPLesion repair; acromio-
clavicular repair, capsular
shift/capsulolabral reconstruction,
deltoid repair, rotator cuff tear repair,
biceps tenodesis
Foot & Ankle : Medial/Lateral
repairand reconstruction, midfoot
and forefoot repair, Hallux valgus
reconstruction, Metatarsal
ligament/tendon repair or
reconstruction, Achilles tendon
repair
Elbow : Ulnar or radial collateral
ligament reconstruction, lateral
epicondylitis repair, biceps
tendonreattachment
Knee : Extra-capsular repair, Medial
collateral ligament (MCL), lateral
collateral ligament (LCL), posterior
oblique ligament, iliotibial band
tenodesis (IBT), patellar tendon
repair, vastus medialis obliquus
advancement(VMO), Joint capsule
closure | These suture anchors are
intended for the fixation of soft
tissue to bone in the Hip,
Shoulder, Foot, Ankle, Elbow,
Wrist, Hand and Knee as
follows:
Hip
Hip capsular repair
-Acetabular labrum
reattachment
Shoulder
Capsular stabilization
-Bankart repair
-Anterior shoulder instability
-SLAP lesion repairs
-Capsular shift or
capsulolabral reconstructions
Acromio-clavicular separation
repair
Deltoid repair
Rotator cuff tear repair
Biceps tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability
repairs/reconstructions | The Smith & Nephew Knotless
Instability Anchor is intended for
reattachment of soft tissue to bone
for following indications:
Hip
• Acetabular labrum reattachment
Shoulder
Capsular stabilization
• Bankart repair
• Anterior shoulder instability
• SLAP lesion repairs
• Capsular shift or capsulolabral
reconstructions
Acromioclavicular separation
repairs
Deltoid repairs
Rotator cuff tear
repairs
Biceps tenodesis
Foot and Ankle
Hallux valgus repairs
Medial or lateral instability
repairs/reconstructions
Achilles tendon
repairs/reconstructions
Metatarsal ligament/tendon repair
or reconstruction
Bunionectomy | |
| | Hand and Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in planx; Volar plate reconstruction
Hip
Acetabular labral repair | Achilles tendon repairs/reconstructions
Midfoot reconstructions
Metatarsal ligament/tendon repair or reconstruction
Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment
• Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Knee
• Extra-capsular repair:
-Medial collateral ligament
-Lateral collateral ligament
-Posterior oblique ligament
Patellar realignment and tendon repairs
-Vastus medialis obliquus advancement
Iliotibial band tenodesis | Elbow, Wrist, and Hand
Biceps tendon reattachment
Ulnar or radial collateral ligament reconstructions
Lateral epicondylitis repair
Knee
Extra-capsular repair:
• Medial collateral ligament
• Lateral collateral ligament
• Posterior oblique ligament
Patellar realignment and tendon repairs
• Vastus medialis obliquus advancement
Iliotibial band tenodesis | | |
| Anchor
Pictorial
representation | Image: Anchor Pictorial representation |
2.8mm
Image: 2.8mm | 1.8mm
1.8 Mini
Image: 1.8mm and 1.8 Mini | Image: poly-ether-ether-ketone (PEEK) | Image: poly-ether-ether-ketone (PEEK) |
| Implant/
Anchor
Material | Polyethylene Terephthalate Fiber (PET) | Same | poly-ether-ether-ketone (PEEK) | poly-ether-ether-ketone (PEEK) | |
| Anchor/
Implant size
(Diameter) | 1.8 mm | 1.8 and 2.8 mm | 3.0 mm | 3.7 mm | |
| Implant
Length (before
deployment) | 10mm | 15mm for 1.8mm Q-Fix Anchor
20mm for 2.8mm Q-Fix Anchor
10mm for 1.8mm Q-Fix MINI anchor | 0.455" (11.557 mm) | 0.480" (12.192 mm) | |
| Bone Hole OD | 0.0875" (2.2 mm) | 2.1mm (0.083") for 1.8mm Q-Fix
Anchor
3.1mm (0.121") for 2.8mm Q-Fix
Anchor | 2.6 mm | 4 mm | |
| Bone hole
depth | 0.71" (18.034 mm) | 22.3mm for 1.8mm Q-Fix Anchor
26.8mm for 2.8mm Q-Fix Anchor
17.1mm for 1.8mm Q-Fix MINI
Anchor | 14 mm | 21.5 mm | |
| Suture Size
(USP) | #0 and #1
Or
MINITAPE (#2) and #1 | #2 | #0 | #2-0 | |
| Number of
Sutures | Q-FIX® with Needles, #0
SUTURE: 3 (#0, #1)
Q-FIX® with Needles,
MINITAPE: 2 (#1, #2) | 1.8mm Q-Fix Anchor: 1 (#2 Suture)
2.8mm Q-Fix Anchor: 2 (#2 Suture) | 2 (#0 Suture) | 1 (#2-0) | |
| Suture
Material | UHMWPE, nonabsorbable
Polypropylene,
nonabsorbable | Same | Same | Same | |
| Inserter Shaft
Material | Stainless Steel | Same | Same | Same | |
| Inserter
Handle
Material | Polycarbonate
ABS
Nylon
Stainless Steel | Polycarbonate
ABS
Nylon
Stainless Steel | Polycarbonate
Stainless Steel
Silicone | Polycarbonate
ABS
Stainless Steel | |
| Labeling | Rx Only,
Sterile, Single-Use | Same | Same | Same | |
| Method of
Sterilization | EtO | EtO | EtO | Gamma | |
| Packaging
Configuration | 2-piece PETG inner tray | 2-piece PETG inner tray | LPDE tip protector in a PE
bag and single Tyvek pouch
inside a CCB outer carton | LPDE tip protector in a PE bag
and single Tyvek pouch inside a
CCB outer carton | |
| Method of
Anchor
Insertion | Insert into a predrilled hole | Same | Same | Same | |
| Suture
Locking
Mechanism | Manually tied suture knot | Manually tied suture | Manually tied suture | Knotless via inner plug
mechanism | |
| Bone Locking
Mechanism | Expandable Compression Fit | Expandable Compression Fit | Steps/ribs | Steps/ribs | |
| Needles provided
in the device | Q-FIX® with Needles
#0, SUTURE: Four (4)
needles
Q-FIX® with Needles,
MINITAPE: Two (2) needles | No | Yes (4). Housed within the
shaft | No | |
| Accessories
used | Drill
Drill guide | Nonsterile, Reusable Drill, Drill
Guide, | 2.3 mm Drill Guide,
2.3 mm Obturator,
2.3 mm Drill Bit | Drill,
Drill Guide,
Obturator | |
Table 2: Comparison of Technological Differences between the Subject device, Predicate devices, and reference device.
9
10
11
12
| Obturator and Sterile, Disposable | Suture Shuttle | |
|---|---|---|
| Drill, Drill | ||
| Guide, Obturator | ||
| Bone Punch, Knot Pusher | ||
| 1.8mm & 2.8mm PathFinder® | ||
| FirstPass® Suture Passer | ||
| FirstPass® ST Suture Passer | ||
| Accu-Pass® Direct Suture Passer | ||
| SpeedStitch® Suture Passer |
13
PERFORMANCE TESTING - NON-CLINICAL 8
For the non-clinical performance testing, both Q-FIX with Needles SKUs have been assessed for the following functional tests:
- Insertion and deployment
- o With the use of the Extremities Guide, Universal and the Drill for Q-FIX with Needles
- Suture slide ●
- Fixation ●
- . Cyclic UTS and displacement
- Needle attachment strength ●
- Knot tensile strength
For the non-clinical performance testing, the Drill for Q-FIX with Needles has been assessed for the following functional tests:
- . Force and torque to drill
- Torque to fail ●
Q-FIX with Needles devices met performance specifications for insertion strength, fixation, cyclic loading, UTS. Therefore, Q-FIX with Needles is equivalent to its predicate devices.
PERFORMANCE TESTING - PRE-CLINICAL 9
There was no pre-clinical testing required for the subject device.
10 PERFORMANCE TESTING - ANIMAL
There was no animal testing required for the subject device.
11 PERFORMANCE TESTING-CLINICAL
There are no clinical studies performed on the subject device
12 STERILIZATION
Q-FIX with Needles devices are sterilized utilizing 100% Etyhlene Oxide (Eto orEO) gas via an existing validated EO Cycle. The evaluation and adoption are based onthe principles outlined in AAMI TIR 28:2016. The sterilization method ensures a minimum sterility assurance level of 10-6.
14
13 SHELF LIFE
Shelf life testing included environmental conditioning (T=0) and accelerated aging studies at T=1 year. Packaging integrity testing included- visual inspection of seal, gross leak (bubble emission), peel strength testing, and manual peel or aseptic presentation.
14 PACKAGING
Q-FIX with Needles devices are supplied sterile and are intended for single use only. The devices are not cleaned or re-sterilized for re-use. All packaging has been validated in accordance with ASTM D4332:2014, ISTA 3A, ISTA 4AB, ISO 11607-1:2019 and ISO 11607-2:2019.
BIOCOMPATIBILITY ાર
Q-FIX with Needles devices include components that are is classified as an externally communicating medical device with tissue/bone/dentin contact with limitedduration (30 days, as per ISO 10993-1:2018. The subject devicemet the acceptance criteria under the conditions of the chemical characterization and biological testing performed.
16 CONCLUSION
All testing demonstrates that the subject devices perform as intended and have acceptable performance when used in accordance with the labeling. The substantial equivalence of Q-FIX with Needles is based on similarities in indications for use, design features, operational principles, material biocompatibility and composition, and performance to the predicate devices and reference devices listed above.