(94 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a manually operated surgical instrument, with no mention of AI or ML capabilities.
No.
The device is described as a surgical instrument used for aspirating bone marrow or blood and as bone screw starters/taps, not for treating a disease or condition.
No
Explanation: The device is described as a surgical instrument used for aspirating bone marrow or autologous blood, and as bone screw starters and bone taps. Its function is to assist in the physical collection of biological material and bone preparation, not to provide diagnostic information or analyses.
No
The device description clearly outlines physical components made of stainless steel and ABS, and the performance studies involve testing of these physical attributes (Luer Lock fitting, air leakage, separation force, etc.). There is no mention of software as a component or function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Imbibe Aspirating XIA Taps™ are surgical instruments used during a surgical procedure to aspirate bone marrow or blood from the body. They are also used for bone preparation (screw starters and taps).
- Intended Use: The intended use clearly states the device is for aspirating bone marrow or autologous blood and for use as bone screw starters and bone taps. It does not mention any analysis or testing of these samples outside the body for diagnostic purposes.
- Device Description: The description focuses on the physical characteristics and function of the instrument for aspiration and bone preparation. It does not describe any components or processes related to in vitro analysis.
The device is a surgical instrument used to collect a sample and prepare bone, not to perform diagnostic testing on that sample.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KNW, LXH
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, sterile packed instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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.
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.
Not Found
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
§ 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.
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.
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March 19,
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Praya King
Re:
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ulation Number: 21 CFR 876.1075
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Ms. King
versions Sector Aldel Presenter Medical Propential Propenter Monder Morania
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on lesire specific add Consumer Education (21 CFR Pat 801).
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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)
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:
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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.
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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™ | ||
| 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 |
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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 876.1075 | ||
| 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 |
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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
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. |