Imbibe Aspirating XIA Taps

K143546 · Stryker Corporation · KNW · Mar 19, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143546
• Device Name: Imbibe Aspirating XIA Taps
• Applicant: Stryker Corporation
• Product Code: KNW · Gastroenterology, Urology
• Decision Date: Mar 19, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

The Imbibe Aspirating XIA Taps™ are for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Aspirating XIA Taps™ are also for use as bone screw starters and bone taps.

Device Story

Manually operated surgical instrument; used to aspirate bone marrow or autologous blood; provides access to cortical bone; functions as bone screw starter and bone tap. Input: manual force applied by surgeon; Output: bone marrow/blood aspirate collected via attached syringe. Used in clinical/surgical settings by physicians. Device is cannulated with fenestrated distal tip; features threaded tip for bone preparation; includes Luer-Lock fitting for syringe connection. Benefits: facilitates bone graft/void filler preparation and screw pathway initiation. Single-use device.

Clinical Evidence

Bench testing and animal model testing performed. Bench testing included Luer Lock fitting, air leakage, separation force, unscrewing torque, and resistance to overriding per ISO 594-2. Animal model testing demonstrated substantial equivalence for bone marrow and autologous blood aspiration functionality. All laboratory tests conducted in compliance with 21 CFR Part 58 (GLP).

Technological Characteristics

Materials: medical grade stainless steel, acrylonitrile butadiene styrene (ABS). Dimensions: 4.5mm to 7.5mm diameters. Features: cannulated, fenestrated distal ends, threaded tip, male Luer-Lock fitting. Biocompatibility: ISO 10993 compliant. Sterilization: sterile packed. Connectivity: none. Energy source: manual.

Indications for Use

Indicated for patients requiring bone marrow or autologous blood aspiration for combination with bone graft or bone void filler, and for use as bone screw starters and bone taps during orthopedic surgical procedures.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Stryker Orthobiologics Imbibe Bone Marrow Aspirate Needle (K050795)

Submission Summary (Full Text)

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n in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic

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# nnifer R. Stevens

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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)

K143546

Device Name Imbibe Aspirating XIA TapsTM

Indications for Use (Describe)

The Imbibe Aspirating XIA Taps M are for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler.

The Imbibe Aspirating XIA TapsTM are also for use as bone screw starters and bone taps.

| 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) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/1 description: The image shows the word "stryker" in a vertical orientation. The letters are in a bold, sans-serif font and are black against a white background. The word is oriented so that it reads from bottom to top.

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Attachment 4 – FDA Additional 510(k) STRYKER SPINE Imbibe Aspirating XIA Taps '™
Attachment 4 – FDA Additional Information Request – Revised Section 009

| Section 009 | | |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Summary: Imbibe Aspirating XIA Taps™<br>Stryker Spine<br>2 Pearl Court<br>Allendale, New Jersey 07401 | |
| Submitter: | | |
| | Soraya King<br>Regulatory Affairs Specialist | |
| Contact Person | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] | |
| Date Prepared | March 3, 2015 | |
| Trade Name | Imbibe Aspirating XIA Taps™ | |
| Device Common Name | Aspirating Biopsy Bone Taps | |
| Proposed Class | Class II | |
| Classification Name<br>and Number | Gastroenterology-urology biopsy instrument, 21 CFR 876.1075<br>Orthopedic manual surgical instrument, 21 CFR 888.4540 | |
| Product Code | KNW<br>LXH | |
| Predicate Devices | The Imbibe Aspirating XIA Taps™ was shown to be<br>substantially equivalent to the devices listed below:<br>• Stryker Orthobiologics Imbibe Bone Marrow Aspirate Needle (K050795) | |
| Device Description | The Imbibe Aspirating XIA Taps™ are manually operated surgical instruments used to assist with aspiration of bone marrow (BMA) and autologous blood by use of a syringe. The taps will be provided in 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5mm, and 7.5mm diameters. The instruments are cannulated with fenestrated distal ends which serve as ports of entry for the BMA and autologous blood. The proximal end of the taps contain an over molded Luer-Lock fitting for syringe connection and BMA/autologous blood extraction. The tips are also threaded to assist in bone preparation and bone screw starter. The main body of the Imbibe Aspirating XIA Taps™ is manufactured from medical grade stainless steel and the Luer-Lock fitting from acrylonitrile butadiene styrene (ABS). The subject device is not intended to be used as a delivery unit.<br><br>All materials used have acceptable biocompatibility results as per ISO 10993. The devices will be provided as single-use. | |
| Section 009 | 510(k) Summary: Imbibe Aspirating XIA Taps™ | |
| Intended Use and<br>Indications for Use | sterile packed instruments. | |
| | The Imbibe Aspirating XIA Taps™ are for use in aspirating<br>bone marrow or autologous blood by use of a syringe. The bone<br>marrow or autologous blood may be combined with bone graft<br>or bone void filler. | |
| | The Imbibe Aspirating XIA Taps™ are also for use as bone<br>screw starters and bone taps. | |
| | Summary of the<br>Technological<br>Characteristics | The Imbibe Aspirating XIA Taps™ are substantially equivalent<br>to the predicate device in terms of function, principals of<br>operation, technological characteristics, materials of<br>construction. The subject Imbibe Aspirating XIA Taps and the<br>predicate Imbibe Needle share similar design features: |
| | | • |
| | | • |
| • | | Affixed with an ABS Luer-Lock fitting for syringe<br>attachment |

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stryker

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Attachment 4 – FDA Additional 510(k) STRYKER SPINE Imbibe Aspirating XIA Taps™
Attachment 4 – FDA Additional Information Request – Revised Section 009

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stryker

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Tetragonal System: TETRAGONAL PRISMATIC (4/m 2/m 2/m) - XIV E. Trapezohedron, F. Trapezohedron, G. Scalenohedron, H. Dipyramid, I. Tetragonal Prismatic Combination, J. Tetragonal Prismatic Combination, K. Tetragonal Prismatic Combination, L. Tetragonal Prismatic Combination.

Attachment 4 – FDA Additional Information Request – Revised Section Imbibe Aspirating XIA Taps
Attachment 4 – FDA Additional Information Request – Revised Section 009

| | " AND THE PREDICATE DEVICE |
|---|-----------------------------------------------|
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| | COMPARISON OF THE IMBIBE ASPIRATING XIA TAPS" |
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| Attribute | Subject Device | Predicate Device | |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Imbibe Aspirating XIA Taps™ | Imbibe Bone Marrow Aspiration Needle | |
| | | 510(k) #K050795 | |
| Indications for Use | The Imbibe Aspirating XIA Taps™ are for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. | The Imbibe Bone Marrow Aspiration Needle is for use in aspirating Bone Marrow or Autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. | |
| | The Imbibe Aspirating XIA Taps™ are also for use as bone screw starters and bone taps. | | |
| Intended Use | Intended to be used as a bone marrow and autologous blood aspirating needle/instrument. Device can also be used to prepare the bone, and initiate a pathway for bone screw insertion. | Intended to be used as a bone marrow and autologous blood aspirating needle/instrument. Device can also be used to prepare the bone, and initiate a pathway for bone screw insertion. | |
| Product Code | KNW - Gastroenterology-urology biopsy instrument, 21 CFR 876.1075<br>LXH - Orthopedic manual surgical instrument, 21 CFR 888.4540 | KNW - Gastroenterology-urology biopsy instrument, 21 CFR 876.1075 | |
| Fenestrated Holes | Distal working-tips contain fenestrations as port of entries for the BMA and autologous blood. | Distal working-tips contain fenestrations as port of entries for the BMA and autologous blood. | |
| Device is<br>Cannulated | Cannulation begins at the fenestrated holes and ends at the Luer Lock fitting attachment point located just below the quick connect handle. | Cannulation begins distal end (tip) and ends at the Luer Lock fitting attachment point located at the top of the device. | |
| Depth Markings on<br>Needle | The laser etching indicates the depth of penetration and helps to determine proper bone screw length. | The laser etching indicates the depth of penetration. | |
| Luer Fitting | Equipped with a male Luer Lock connection for syringe attachment to be used BMA and autologous blood extractions. | Equipped with a male Luer Lock connection for syringe attachment to be used BMA and autologous blood extractions. | |
| Syringe | Any commercially available surgical grade syringe equipped with a female Luer Lock fitting. Syringe not provided with device. | Any commercially available surgical grade syringe equipped with a female Luer Lock fitting. Syringe not provided with device. | |
| | COMPARISON OF THE IMBIBE ASPIRATING XIA TAPS™ AND THE PREDICATE DEVICE | | |
| Attribute | Subject Device | Predicate Device | |
| | Imbibe Aspirating XIA Taps™ | Imbibe Bone Marrow Aspiration Needle | |
| | | 510(k) #K050795 | |
| Working-Tip Design | Threaded Needle Tip | Smooth Pointed Needle Tip (Trocar Tip Stylet) or Smooth Blunt Needle Tip (Bullet Tip Stylet) | |
| Handle Design | Compatible with several Stryker handles with a slot groove connection point. Varied handle styles to accommodate surgeon's preference. Handle is not included with the device. | Asymmetric handle-contour fit the physician's hand. Handle is part of the design of the device. | |
| Sizes | Available in diameters of 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5mm, and 7.5mm | Various sizes | |
| Principle of Operation | Once access to the desired anatomical surgical site is obtained, the subject device can be used to pierce through the cortical bone layer, prepare the bone, initiate a bone screw pathway, and aspirate BMA/autologous blood. A surgical grade syringe is attached to the mating Luer Lock Fitting to collect the bone marrow and blood aspirate. Aspiration is achieved when the syringe plunger is pulled back. The collected BMA/autologous blood can be mixed with bone void filler or bone graft material such as allograft, autograft, or synthetic bone graft. | Once access to the desired anatomical surgical site is obtained, the subject device can be used to pierce through the cortical bone layer, prepare the bone, initiate a bone screw pathway, and aspirate BMA/autologous blood. A surgical grade syringe is attached to the mating Luer Lock Fitting to collect the bone marrow and blood aspirate. Aspiration is achieved when the syringe plunger is pulled back. The collected BMA/autologous blood can be mixed with bone void filler or bone graft material such as allograft, autograft, or synthetic bone graft. | |
| Biocompatible | Stainless Steel, ABS | Stainless Steel, ABS | |

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Functional Annotation:
FTO(K510R)TRYKTRRRSRFRNELELIRASPEIMBINE. Training & Subcellular Localization: XIA Taps

attachment 4 – FDA Additional Information Request – Revised SPINE Imbibe Aspirating XIA Taps
Revised Section Request – Revised Section 009

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Image /page/7/Picture/1 description: The image shows the word "stryker" in a vertical orientation. The letters are in a bold, sans-serif font and are black. The word is oriented so that the letters are stacked on top of each other.

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THE HIKING TRAPS
(A Combination of "Hiking" and "Traps")

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Attachment 4 – FDA Additional Information Request – Revised SPINE Imbibe Aspirating XIA Taps
Attachment 4 – FDA Additional Information Request – Revised Section 009

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2 Pearl Court
Alleudale, NJ 07401
t: 866 45 SIPINE
t: 866 45 SIPINE
www.stryker.com

stryker

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Attachment 4 – FDA Additional 510(k) STRYKER SPINE Imbibe Aspirating XIA Taps™
Attachment 4 – FDA Additional Information Request – Revised Section 009

| Summary of<br>Non-Clinical Testing | Performance testing was conducted for the Imbibe Aspirating<br>XIA TapsTM and demonstrated substantially equivalent<br>performance to the identified predicate device system.<br><br>The following tests were performed:<br>• Luer Lock Fitting (per ISO 594-2)<br>• Air Leakage (per ISO 594-2)<br>• Separation Force of the Luer Lock Fitting (per ISO 594-2)<br>• Unscrewing Torque (ISO 594-2)<br>• Resistance to Overriding (per ISO 594-2)<br>• Pre-clinical testing was conducted using an animal model to<br>demonstrate substantial equivalency performance of the bone<br>marrow and autologous blood aspiration functionality.<br>Laboratory tests were conducted in compliance with<br>applicable Good Laboratory Practices (GLP) requirements<br>stipulated in 21 CFR Part 58. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | Based upon a comparison of intended use, technological<br>characteristics, and device performance in the non-clinical<br>testing listed above, the Imbibe Aspirating XIA TapsTM has<br>demonstrated substantial equivalence to the identified predicate<br>device system. |