← Product Code [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW) · K143546 # Imbibe Aspirating XIA Taps (K143546) _Stryker Corporation · KNW · Mar 19, 2015 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K143546 ## Device Facts - **Applicant:** Stryker Corporation - **Product Code:** [KNW](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW.md) - **Decision Date:** Mar 19, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1075 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## 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 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. ## Regulatory 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](/device/K050795.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design with three curved lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure in a circular pattern. and Drug Administratio 6 New Hampshire Avento ment Control Control - V ment Control Control - V Spring, MD 20993-00 March 19, endale, New Jersey tory Affairs Court er Corporat Praya King Re: le/Device Name: Imbibe Aspirating XIA Taps™ ulation Number: 21 CFR 876.1075 ulation Name: Gastroenterology-urology biopsy instrume KNW Decembe Ms. King versions Sector Aldel Presenter Medical Propential Propenter Monder Morania Sunation Comments March Comments March Manuel Manager Manager Manager Manner Manufa National Comme evice is classified (see above) into either class II (Special Controls) or class III subject to additional controls. Existing major regulations affecting your levin, FDA r o advised that FDA is issumo of a substantial equivalone detemintina doces not. Fedula made a dreprimente vormics verilier with alternation and more and markation and and and {1}------------------------------------------------ n in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic on lesire specific add Consumer Education (21 CFR Pat 801). 2017 05-11sion at Consumer Education at its foll-free mul. 2017 07-17 in themates and Consumer Education. Ast (and http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to R Part 803), please go to p://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Surveillance and Biometrics/Division of Postmarket Surveillance. may obtain other general information on your responsibilities under the Act from sion of Industry and Consumer Education at its toll-free number (800) 638-2041) 7100 or at it http://www.fcc.gov/media/resources/reports Incerely yours # nnifer R. Stevens Ashar, M.D., M.B.A., I vision of Surgical Device Evaluati Tice of Device Evaluati Inter for Devices and Radiological Health Enclosure {2}------------------------------------------------ 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. 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}------------------------------------------------ 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. Spine 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™
Stryker Spine
2 Pearl Court
Allendale, New Jersey 07401 | | | Submitter: | | | | | Soraya King
Regulatory Affairs Specialist | | | Contact Person | Phone: 201-760-8296
Fax: 201-962-4296
Email: Soraya.King@Stryker.com | | | Date Prepared | March 3, 2015 | | | Trade Name | Imbibe Aspirating XIA Taps™ | | | Device Common Name | Aspirating Biopsy Bone Taps | | | Proposed Class | Class II | | | Classification Name
and Number | Gastroenterology-urology biopsy instrument, 21 CFR 876.1075
Orthopedic manual surgical instrument, 21 CFR 888.4540 | | | Product Code | KNW
LXH | | | Predicate Devices | The Imbibe Aspirating XIA Taps™ was shown to be
substantially equivalent to the devices listed below:
• 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.

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
Indications for Use | sterile packed instruments. | | | | 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. | | | | Summary of the
Technological
Characteristics | The Imbibe Aspirating XIA Taps™ are substantially equivalent
to the predicate device in terms of function, principals of
operation, technological characteristics, materials of
construction. The subject Imbibe Aspirating XIA Taps and the
predicate Imbibe Needle share similar design features: | | | | • | | | | • | | • | | Affixed with an ABS Luer-Lock fitting for syringe
attachment | {4}------------------------------------------------ stryker Spine Attachment 4 – FDA Additional 510(k) STRYKER SPINE Imbibe Aspirating XIA Taps™ Attachment 4 – FDA Additional Information Request – Revised Section 009 {5}------------------------------------------------ stryker Spine 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 | |---|-----------------------------------------------| | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | COMPARISON OF THE IMBIBE ASPIRATING XIA TAPS" | | | | | | | | | | | 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
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
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
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 | | {6}------------------------------------------------ stryker Spine 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 {7}------------------------------------------------ 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. Spine THE HIKING TRAPS (A Combination of "Hiking" and "Traps") Try to be As Original 51 (K) Attachment 4 – FDA Additional Information Request – Revised SPINE Imbibe Aspirating XIA Taps Attachment 4 – FDA Additional Information Request – Revised Section 009 {8}------------------------------------------------ 2 Pearl Court Alleudale, NJ 07401 t: 866 45 SIPINE t: 866 45 SIPINE www.stryker.com stryker Spine Attachment 4 – FDA Additional 510(k) STRYKER SPINE Imbibe Aspirating XIA Taps™ Attachment 4 – FDA Additional Information Request – Revised Section 009 | Summary of
Non-Clinical Testing | Performance testing was conducted for the Imbibe Aspirating
XIA TapsTM and demonstrated substantially equivalent
performance to the identified predicate device system.

The following tests were performed:
• Luer Lock Fitting (per ISO 594-2)
• Air Leakage (per ISO 594-2)
• Separation Force of the Luer Lock Fitting (per ISO 594-2)
• Unscrewing Torque (ISO 594-2)
• Resistance to Overriding (per ISO 594-2)
• Pre-clinical testing was conducted using an animal model to
demonstrate substantial equivalency performance of the bone
marrow and autologous blood aspiration functionality.
Laboratory tests were conducted in compliance with
applicable Good Laboratory Practices (GLP) requirements
stipulated in 21 CFR Part 58. | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Conclusion | Based upon a comparison of intended use, technological
characteristics, and device performance in the non-clinical
testing listed above, the Imbibe Aspirating XIA TapsTM has
demonstrated substantial equivalence to the identified predicate
device system. | --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K143546](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/KNW/K143546) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com