(94 days)
The Imbibe Aspirating XIA TapsTM 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.
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, sterile packed instruments.
The provided text describes the Stryker Imbibe Aspirating XIA Taps™ and its FDA 510(k) submission, comparing it to a predicate device. The information focuses on proving substantial equivalence to the predicate device rather than presenting a study demonstrating new device performance against defined acceptance criteria. Therefore, several requested fields cannot be directly extracted from this document, as it's not a study report in that sense.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative format for the new device as it does for a clinical trial. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is stated in terms of compliance with ISO standards and successful outcomes in pre-clinical animal testing.
| Acceptance Criteria (Implied by Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: | |
| Luer Lock Fitting strength and integrity | Passed Luer Lock Fitting (ISO 594-2) |
| Air Leakage | Passed Air Leakage (ISO 594-2) |
| Separation Force of Luer Lock Fitting | Passed Separation Force (ISO 594-2) |
| Unscrewing Torque | Passed Unscrewing Torque (ISO 594-2) |
| Resistance to Overriding | Passed Resistance to Overriding (ISO 594-2) |
| Bone marrow/autologous blood aspiration | Demonstrated substantial equivalency in animal model |
| Bone screw starter/bone tap functionality | Demonstrated substantial equivalency in animal model |
| Biocompatibility: | |
| Material Biocompatibility | All materials used have acceptable biocompatibility results as per ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for each test. For the pre-clinical animal model, the sample size is not specified.
- Data Provenance: The pre-clinical testing was conducted in a laboratory setting. The country of origin of the data is not specified in the provided text. The testing appears to be prospective as it was conducted specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The document describes pre-clinical engineering and animal model testing, not studies requiring expert review of data for ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers evaluate cases, such as in image-based diagnostic studies, to establish ground truth or resolve discrepancies. This document focuses on device performance metrics and an animal model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document focuses on the substantial equivalence of the device's functional and material characteristics to a predicate device, not on comparing human reader performance with or without the device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. This is a medical device (surgical instrument), not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the functional tests like Luer Lock fitting and air leakage, the "ground truth" is adherence to the specified ISO standard thresholds. For the pre-clinical animal model, the "ground truth" would be the successful aspiration of bone marrow/autologous blood and the ability to function as a bone screw starter/tap, demonstrated by the animal study results.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI or machine learning model that requires a training set. The "training set" concept is not relevant to proving substantial equivalence for a mechanical medical device.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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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.
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n in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
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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)
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.
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 Spine2 Pearl CourtAllendale, New Jersey 07401 | ||
| Submitter: | ||
| Soraya KingRegulatory Affairs Specialist | ||
| Contact Person | Phone: 201-760-8296Fax: 201-962-4296Email: 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 Nameand Number | Gastroenterology-urology biopsy instrument, 21 CFR 876.1075Orthopedic manual surgical instrument, 21 CFR 888.4540 | |
| Product Code | KNWLXH | |
| Predicate Devices | The Imbibe Aspirating XIA Taps™ was shown to besubstantially 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 andIndications for Use | sterile packed instruments. | |
| The Imbibe Aspirating XIA Taps™ are for use in aspiratingbone marrow or autologous blood by use of a syringe. The bonemarrow or autologous blood may be combined with bone graftor bone void filler. | ||
| The Imbibe Aspirating XIA Taps™ are also for use as bonescrew starters and bone taps. | ||
| Summary of theTechnologicalCharacteristics | The Imbibe Aspirating XIA Taps™ are substantially equivalentto the predicate device in terms of function, principals ofoperation, technological characteristics, materials ofconstruction. The subject Imbibe Aspirating XIA Taps and thepredicate Imbibe Needle share similar design features: | |
| • | ||
| • | ||
| • | Affixed with an ABS Luer-Lock fitting for syringeattachment |
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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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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 876.1075LXH - 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 isCannulated | 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 onNeedle | 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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stryker
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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")
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
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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 ofNon-Clinical Testing | Performance testing was conducted for the Imbibe AspiratingXIA TapsTM and demonstrated substantially equivalentperformance 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 todemonstrate substantial equivalency performance of the bonemarrow and autologous blood aspiration functionality.Laboratory tests were conducted in compliance withapplicable Good Laboratory Practices (GLP) requirementsstipulated in 21 CFR Part 58. |
|---|---|
| Conclusion | Based upon a comparison of intended use, technologicalcharacteristics, and device performance in the non-clinicaltesting listed above, the Imbibe Aspirating XIA TapsTM hasdemonstrated substantial equivalence to the identified predicatedevice system. |
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.