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.

AI/ML Overview

The provided text is a 510(k) summary for the O-FIX With Needles device, a medical device for reattaching soft tissue to bone. It does not contain information about acceptance criteria and study results for an AI/ML device. The document describes the device itself, its intended use, comparison with predicate devices, and non-clinical performance testing.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance for an AI/ML device.
Sample size used for the test set and data provenance for an AI/ML study.
Number of experts and their qualifications for establishing ground truth for an AI/ML study.
Adjudication method for an AI/ML study.
MRMC comparative effectiveness study results for an AI/ML device.
Standalone performance for an AI/ML algorithm.
Type of ground truth used for an AI/ML device.
Sample size for the training set and how its ground truth was established for an AI/ML device.

The document states under "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
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."

This is the only information provided regarding "acceptance criteria" and "device performance" in the context of the physical device. The study is a non-clinical performance testing intended to demonstrate substantial equivalence to predicate devices, not an AI/ML model.

Summary

{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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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)

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

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 (1.8mmQ-FIX Mini,1.8 Q-FIX2.8 Q-FIX (PrimaryPredicate)(K172165)	Raptormite 3.0 PKSuture Anchor(SecondaryPredicate Device)(K071586)	Smith & Nephew KnotlessInstability Anchor orBioraptor Knotless SutureAnchor(Reference Device)(K093428)
Intended Use	Reattachment of soft tissue tobone	Same	Same	Same
Indications forUse	Q-FIX with Needles use is onlyintended for the reattachment ofsoft tissue to bone for thefollowing indications:Foot and Ankle• Medial or lateral instabilityrepairs/ reconstructions• Achilles tendon repairs/reconstructions	The Q-Fix Suture Anchor is intendedto be used for soft tissue to bonefixation for:Shoulder : Bankart lesion repair,SLAPLesion repair; acromio-clavicular repair, capsularshift/capsulolabral reconstruction,deltoid repair, rotator cuff tear repair,biceps tenodesisFoot & Ankle : Medial/Lateralrepairand reconstruction, midfootand forefoot repair, Hallux valgusreconstruction, Metatarsalligament/tendon repair orreconstruction, Achilles tendonrepairElbow : Ulnar or radial collateralligament reconstruction, lateralepicondylitis repair, bicepstendonreattachmentKnee : Extra-capsular repair, Medialcollateral ligament (MCL), lateralcollateral ligament (LCL), posterioroblique ligament, iliotibial bandtenodesis (IBT), patellar tendonrepair, vastus medialis obliquusadvancement(VMO), Joint capsuleclosure	These suture anchors areintended for the fixation of softtissue to bone in the Hip,Shoulder, Foot, Ankle, Elbow,Wrist, Hand and Knee asfollows:HipHip capsular repair-Acetabular labrumreattachmentShoulderCapsular stabilization-Bankart repair-Anterior shoulder instability-SLAP lesion repairs-Capsular shift orcapsulolabral reconstructionsAcromio-clavicular separationrepairDeltoid repairRotator cuff tear repairBiceps tenodesisFoot and AnkleHallux valgus repairsMedial or lateral instabilityrepairs/reconstructions	The Smith & Nephew KnotlessInstability Anchor is intended forreattachment of soft tissue to bonefor following indications:Hip• Acetabular labrum reattachmentShoulderCapsular stabilization• Bankart repair• Anterior shoulder instability• SLAP lesion repairs• Capsular shift or capsulolabralreconstructionsAcromioclavicular separationrepairsDeltoid repairsRotator cuff tearrepairsBiceps tenodesisFoot and AnkleHallux valgus repairsMedial or lateral instabilityrepairs/reconstructionsAchilles tendonrepairs/reconstructionsMetatarsal ligament/tendon repairor reconstructionBunionectomy
	Hand and Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in planx; Volar plate reconstructionHipAcetabular labral repair	Achilles tendon repairs/reconstructionsMidfoot reconstructionsMetatarsal ligament/tendon repair or reconstructionBunionectomyElbow, Wrist, and HandBiceps tendon reattachment• Ulnar or radial collateral ligament reconstructionsLateral epicondylitis repairKnee• Extra-capsular repair:-Medial collateral ligament-Lateral collateral ligament-Posterior oblique ligamentPatellar realignment and tendon repairs-Vastus medialis obliquus advancementIliotibial band tenodesis	Elbow, Wrist, and HandBiceps tendon reattachmentUlnar or radial collateral ligament reconstructionsLateral epicondylitis repairKneeExtra-capsular repair:• Medial collateral ligament• Lateral collateral ligament• Posterior oblique ligamentPatellar realignment and tendon repairs• Vastus medialis obliquus advancementIliotibial band tenodesis
AnchorPictorialrepresentation	Image: Anchor Pictorial representation	2.8mmImage: 2.8mm	1.8mm1.8 MiniImage: 1.8mm and 1.8 Mini	Image: poly-ether-ether-ketone (PEEK)	Image: poly-ether-ether-ketone (PEEK)
Implant/AnchorMaterial	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
ImplantLength (beforedeployment)	10mm	15mm for 1.8mm Q-Fix Anchor20mm for 2.8mm Q-Fix Anchor10mm 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-FixAnchor3.1mm (0.121") for 2.8mm Q-FixAnchor	2.6 mm	4 mm
Bone holedepth	0.71" (18.034 mm)	22.3mm for 1.8mm Q-Fix Anchor26.8mm for 2.8mm Q-Fix Anchor17.1mm for 1.8mm Q-Fix MINIAnchor	14 mm	21.5 mm
Suture Size(USP)	#0 and #1OrMINITAPE (#2) and #1	#2	#0	#2-0
Number ofSutures	Q-FIX® with Needles, #0SUTURE: 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)
SutureMaterial	UHMWPE, nonabsorbablePolypropylene,nonabsorbable	Same	Same	Same
Inserter ShaftMaterial	Stainless Steel	Same	Same	Same
InserterHandleMaterial	PolycarbonateABSNylonStainless Steel	PolycarbonateABSNylonStainless Steel	PolycarbonateStainless SteelSilicone	PolycarbonateABSStainless Steel
Labeling	Rx Only,Sterile, Single-Use	Same	Same	Same
Method ofSterilization	EtO	EtO	EtO	Gamma
PackagingConfiguration	2-piece PETG inner tray	2-piece PETG inner tray	LPDE tip protector in a PEbag and single Tyvek pouchinside a CCB outer carton	LPDE tip protector in a PE bagand single Tyvek pouch inside aCCB outer carton
Method ofAnchorInsertion	Insert into a predrilled hole	Same	Same	Same
SutureLockingMechanism	Manually tied suture knot	Manually tied suture	Manually tied suture	Knotless via inner plugmechanism
Bone LockingMechanism	Expandable Compression Fit	Expandable Compression Fit	Steps/ribs	Steps/ribs
Needles providedin the device	Q-FIX® with Needles#0, SUTURE: Four (4)needlesQ-FIX® with Needles,MINITAPE: Two (2) needles	No	Yes (4). Housed within theshaft	No
Accessoriesused	DrillDrill guide	Nonsterile, Reusable Drill, DrillGuide,	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 (<24 h) and Implant, >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.

Regulation Number and Section

N/A