(56 days)
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is intended for vertebral body access, biopsy and infusion during a vertebroplasty procedure.
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set consists of a cannula with an accompanying inner stylet and an obturator. The device may include an additional inner biopsy needle and obturator. The cannula is available in several sizes (11, 13 or 15 gauge) and lengths (10 or 15 cm) with various cannula/stylet tip configurations. The additional inner biopsy needle is available in two sizes (14 or 16 gauge) and lengths (17.1 or 22.1 cm) with a trephine tip and functions coaxially with the cannula once the stylet is removed. A plastic, non-radiopaque needle holder is also available to aid with needle placement.
The provided document does not contain information related to software or AI/ML-driven medical devices. Therefore, it is impossible to extract the requested details such as acceptance criteria for AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
The document discusses a physical medical device, the "Osteo-Site Bone Biopsy Needle and the Osteo-Site Bone Biopsy Needle Set," and its substantial equivalence to a predicate device. The performance data presented refers to mechanical and biocompatibility testing of this physical device.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details relevant to AI/ML device performance based on the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Cook Incorporated Ms. Erum Nasir, MS Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404
Re: K170008
Trade/Device Name: Osteo-Site Bone Biopsy Needle. Osteo-Site Bone Biopsy Needle Set Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: December 30, 2016 Received: January 3, 2017
Dear Ms. Nasir:
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. 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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170008
Device Name
Osteo-Site® Bone Biopsy Needle and the Osteo-Site® Bone Biopsy Needle Set
Indications for Use (Describe)
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is intended for vertebral body access, biopsy and infusion during a vertebroplasty procedure.
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)
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2.0 510(k) SUMMARY
Osteo-Site® Bone Biopsy Needle and the Osteo-Site® Bone Biopsy Needle Set 21 CFR §807.92 Date Prepared: December 30, 2016
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Erum Nasir, MS |
| Applicant Address: | Cook Incorporated750 Daniels WayBloomington, IN 47404 |
| Contact Phone Number: | (812) 335-3575 x102607 |
| Contact Fax Number: | (812) 332-0281 |
| Device Information: | |
| Trade Name: | Osteo-Site® Bone Biopsy Needle and the OsteoSite® Bone Biopsy Needle Set |
| Common Name: | Instrument, Biopsy |
| Classification Name: | Gastroenterology-Urology Biopsy Instrument |
| Classification Regulation: | 21 CFR §876.1075, Product Code KNW |
Device Class/Classification Panel: Class II, Gastroenterology/Urology
Predicate Devices:
- Stryker Bone and Vertebral Body Biopsy Kit (K032943) ●
Device Description:
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set consists of a cannula with an accompanying inner stylet and an obturator. The device may include an additional inner biopsy needle and obturator. The cannula is available in several sizes (11, 13 or 15 gauge) and lengths (10 or 15 cm) with various cannula/stylet tip configurations. The additional inner biopsy needle is available in two sizes (14 or 16 gauge) and lengths (17.1 or 22.1 cm) with a trephine tip and functions coaxially with the cannula once the stylet is removed. A plastic, non-radiopaque needle holder is also available to aid with needle placement.
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Intended Use:
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is intended for vertebral body access, biopsy and infusion during a vertebroplasty procedure.
Comparison to Predicate Devices:
The Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set is substantially equivalent to the predicate device, the Stryker Bone and Vertebral Body Biopsy Kit (K032943), in that these devices have similar indications for use, technological characteristics, design, and method of placement. The differences between the subject devices and the predicate devices are shown in the table below and include the materials, dimensions, cannula/stylet tip configurations, sterilization method, and included components. These minor differences were appropriately assessed and do not raise new questions regarding safety or effectiveness.
| Stryker Bone and VertebralBiopsy Kit (K032943) | Osteo-Site® Bone Biopsy Needleand Set -Proposed Device | |
|---|---|---|
| Regulation | 876.1075 | Identical |
| Product Code | KNW | Identical |
| Classification | II | Identical |
| Intended Use | Stryker's bone and vertebralbody biopsy kits can be usedas a biopsy tool to remove asample of bone tissue from avertebral body for diagnosticpurposes using a coring,cutting or aspiration technique. | This device is intended for vertebralbody access, biopsy and infusionduring a vertebroplasty procedure. |
| Ancillary DeviceInformation | Stryker IntroductionCannula/Stylet is soldseparately, but required toaccess the vertebral body toperform a biopsy with theStryker Bone and VertebralBiopsy Kit | N/AThe Cannula/Stylet combination isincluded as a component in the Osteo-Site® Bone Biopsy Needle Set and issubject of this submission. |
| Anatomical Site | Vertebral Body | Identical |
| Method of Placement | Percutaneous | Identical |
| Biopsy technique | Coring/Cutting/Suction | Not specified |
| Biopsy Component | Inner Biopsy Needle | Cannula/Inner Biopsy Needle* |
Substantial Equivalence Table
- The proposed set includes the inner biopsy needle and obturator.
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| Substantial Equivalence Table (cont'd) | |||
|---|---|---|---|
| Stryker Bone and VertebralBiopsy Kit (K032943) | Osteo-Site® Bone Biopsy Needleand Set -Proposed Device | ||
| Cannula** | Material | Stainless Steel | Identical |
| Gauge | 10, 11, 13 | 11, 13, 15 | |
| Length (cm) | 12.7 | 10, 15 | |
| TipConfiguration | Four-Facet | Tapered, Bevel, Franseen | |
| Stylet** | Material | Stainless Steel | Identical |
| TipConfiguration | Diamond, Bevel | Scoop, Trocar, Bevel, Diamond | |
| InnerBiopsyNeedle* | Material | Stainless Steel | Identical |
| Gauge | 10, 11, 13 | 14, 16 | |
| Length (cm) | 12.7, 22.9 | 17.1, 22.1 | |
| TipConfiguration | Four-Facet | Trephine | |
| Obturator* | Material | Stainless Steel | Identical |
| Number | One | One or Two | |
| Handle Material | Unknown | ABS/Polycarbonate | |
| Accessories | Syringe | Needle Holder | |
| Obturator Material | Stainless Steel | Identical | |
| Sterilization Method | Gamma Irradiation,VDmax25 | EtO | |
| Sterilization Assurance Level | 10-6 | 10-6 | |
| Packaging | Peel pouch | Tyvek peel pouch |
Substantial Equivalence Table (cont'd)
- The proposed set includes the inner biopsy needle and obturator.
** Stryker Introduction Cannula/Stylet is listed under product code OAR and sold separately, but is required to access the vertebral body to perform a biopsy with the Stryker Bone and Vertebral Biopsy Kit cleared under K032943. Predicate IFU and brochure is provided in Appendix B (Page B-6 and B-9, respectively) for reference purpose only.
Performance Data:
The following tests were performed to demonstrate that the proposed Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set met the applicable design and performance requirements and support a determination of substantial equivalence. Where applicable, testing was done per applicable ISO and other international standards.
- . Compatibility and Dimension Analysis (Cannula, Stylet, Obturator, Inner biopsy needle, Inner biopsy needle obturator) - Testing demonstrated that the devices function as intended.
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- . Tensile Testing (Cannula, Stylet, Obturator, Inner biopsy needle, Inner biopsy needle obturator, and Needle holder) - Testing demonstrated that the devices withstand peak load values greater than the predetermined acceptance criterion.
- Torque Strength Testing (Cannula, stylet, Inner biopsy needle) Testing . demonstrated that the devices withstand torque forces greater than the predetermined acceptance criterion.
- Torsional Override Testing (Cannula) Testing demonstrated that the devices ● withstand torsional load greater than the predetermined acceptance criterion.
- Compression Strength Testing (Cannula and stylet assembly, Inner biopsy needle) . – Testing demonstrated that the devices withstand compression forces greater than the predetermined acceptance criterion.
- . Resistance to Breakage Testing (Cannula and stylet assembly)- Testing demonstrated that the devices function as intended.
- Biopsy Testing (Cannula and inner biopsy needle) Testing demonstrated that the . devices function as intended.
- . Biocompatibility Testing - Testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, partial thromboplastin time, and complement activation) shows that the devices are biocompatible.
Conclusion:
The results of these tests support a conclusion that the Osteo-Site® Bone Biopsy Needle and Osteo-Site® Bone Biopsy Needle Set met the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, Stryker Bone and Vertebral Body Biopsy Kit (K032943).
§ 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.