(229 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a surgical blade and its use in bone cutting. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a cutting accessory (blade) intended to cut bone, not to treat a disease or condition.
No
The device is described as a "cutting accessory intended to cut bone," indicating a therapeutic or surgical function, not a diagnostic one.
No
The device is a physical cutting accessory (a blade) intended to cut bone, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut bone in the posterior canal wall during an Otology procedure." This is a surgical tool used in vivo (within the body) for a surgical procedure.
- Device Description: The description confirms it's a "sterile, single use cutting accessory which is operated by a surgical drill (handpiece)" to remove bone material. This is a mechanical surgical instrument.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a surgical instrument used directly on the patient's bone during surgery, not for analyzing samples in a lab setting.
N/A
Intended Use / Indications for Use
Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.
Product codes (comma separated list FDA assigned to the subject device)
EQJ
Device Description
Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
posterior canal wall
Indicated Patient Age Range
General
Intended User / Care Setting
surgeon
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)
The following verification tests were performed which demonstrates that the device meets the performance requirements under its indications for use conditions.
- Kerf Width Testing
- Life, Simulated Use Testing
- Temperature Testing
Simulated use of a canal wall reconstruction was completed with 3 ENT surgeons for the specific indication in fresh cadaveric Human temporal bone. To supplement this cadaveric study design validation was also completed for the specific indication using PHACON's Temporal Bone Model with 8 ENT surgeons. This model was selected as a suitable cut media for design validation following a technical evaluation along with expert medical opinion. Collectively, the results of these performance tests demonstrate the functionality, integrity, safety and effectiveness of Stryker's Precision Thin Reciprocating Blade, 0.010in. for its intended use and support a determination of substantial equivalence to the regulation 21 CFR 874.4140 (ENT bur).
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.
Not Found
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.
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
§ 874.4140 Ear, nose, and throat bur.
(a)
Identification. An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The graphic element features a stylized depiction of what appears to be an abstract human form or a symbol representing health and human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 17, 2017
Stryker Instruments Dr. Joanna McCarthy Senior Regulatory Affairs Specialist Stryker Corporation 4100 E. Milham Ave. Kalamazoo, MI 49009
Re: K161514
Trade/Device Name: Precision Thin Reciprocating Blade, 0.010in Regulation Number: 21 CFR 874.4140 Regulation Name: Ear, Nose, and Throat Bur Regulatory Class: Class I Product Code: EQJ Dated: December 13, 2016 Received: December 15, 2016
Dear Dr. McCarthy:
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.
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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.
Eric A. Mann -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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. |
| 10(k) Number (if known) | 161514 |
|---|---|
| ------------------------- | -------- |
ייעוץ (אוסורפ
Indications for Use (Describe)
นาย 1 ค.ศ. 1984 - 1992 - 1992 - 1992 - 1992 - 1992 - 1982 - 1982 - 1992 - 1992 - 1992 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1997 - 1
| 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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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
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3
510(k) Number: K161514
Section 5.1 Submitter
510(k) Owner: Stryker Instruments,
4100 E. Milham Avenue,
Kalamazoo,
MI 49001, USA
Phone: 269-323-7700
Fax: 269-389-5412
Contact Person: Joanna McCarthy PhD, Senior Regulatory Affairs Specialist
Date Prepared: 27th May 2016
Section 5.2 Device Information
Trade Name: Precision Thin Reciprocating Blade, 0.010in. Device Common Name: ENT Bur Classification Name: Bur, Ear, Nose and Throat
| FDA Product Code | Device | Regulation Number | Class |
|---|---|---|---|
| EQJ | Bur, Ear, Nose and Throat | 21 CFR 874.4140 | I |
Table 5-1. Classification Data for Precision Thin Reciprocating Blade, 0.010in.
4
Section 5.3 Comparison against Regulation
Stryker currently markets 31 similar devices within the micro reciprocating saw blade family which are independently listed under the FDA product code EQJ. In this premarket notification all 31 devices covered under the EQJ requlation are compared to the subject device Precision Thin Reciprocating Blade, 0.010in based on their technological characteristics and general ENT indications. It is only the addition of the specific indication for the subject device Precision Thin Reciprocating Blade, 0.010in. that is being compared to the following regulation;
Regulation Description: Ear, Nose and Throat Bur Regulation Number: 21 CFR 874.4140
Section 5.4 Reference Device
| Device Name: | Micro Reciprocating Saw Blade (REF MR-0580) |
|---|---|
| Type: | Reference Device |
| 510(K) Number: | K131053- “ANSPACH XMAX, EMAX2 and EMAX2 Plus |
| System with Otologic Attachment System” cleared under | |
| FDA Product Codes ERL and EQJ. | |
| Description: | The primary comparator device (ENT Regulation 21CFR |
| 874.4140) has successfully addressed decision points 1 to 4 | |
| in the 510(k) Decision Making Flowchart as per FDA) | |
| Guidance for Industry and FDA Staff, The 510(k) Program: | |
| Evaluating Substantial Equivalence in Premarket | |
| Notifications [510(k)], dated July 28, 2014. |
However, the technological characteristics (design and
material) of the Precision Thin Reciprocating Blade, 0.010in
is compared to Anspach Micro Reciprocating Saw Blade,
which is cleared through the 510(k) - K131053 |
The Anspach Effort, Inc .:
Table 5-2. Classification Data for Reference Device.
Section 5.5 Device Description
Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.
5
Section 5.6 Indications for Use
Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.
6
Section 5.7 Comparison of Technological Characteristics against Regulation 21 CFR 874.4140 (ENT Burs) and reference device.
| Feature | Comparator ENT Bur (21 CFR 874.4140) | Subject Device: Precision Thin Reciprocating Blade,
0.010in. | Justification |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Product Class | Class I | Class I | Identical |
| Regulation | 21 CFR 874.4140 - Bur, ear, nose and throat | 21 CFR 874.4140 - Bur, ear, nose and throat | Identical |
| FDA Product Code | EQJ - Bur Ear, Nose and Throat | EQJ - Bur Ear, Nose and Throat | Identical |
| Intended Function | Intended to cut bone. | Intended to cut bone. | Identical |
| Patient Population | General | General | Identical |
| Indications For Use | An ear, nose, and throat bur is a device consisting
of an interchangeable drill bit that is intended for
use in an ear, nose, and throat electric or
pneumatic surgical drill (874.4250) for incising or
removing bone in the ear, nose, or throat area.
The bur consists of a carbide cutting tip on a
metal shank or a coating of diamond on a metal
shank. The device is used in mastoid surgery,
frontal sinus surgery, and surgery of the facial
nerves. | Stryker's Precision Thin Reciprocating Blade, 0.010 inch
(REF 5100-437-010) is a sterile, single use cutting accessory
intended to cut bone in the posterior canal wall during an
Otology procedure. | Similar |
| Contraindications | None known | None known | Identical |
7
| Feature | Comparator ENT Bur (21 CFR 874.4140) | Subject Device: Precision Thin Reciprocating
Blade, 0.010in. | Justification |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Conditions for Use | Single Use | Single Use | Identical |
| Principle of
operation
/Mechanism of
Action | Legally marketed micro reciprocating blades listed
under FDA product code EQJ (ENT Bur) are used in
conjunction with an electric reciprocating handpiece
(CORETM Reciprocating Saws), a CORETM Console
and a footswitch or handswitch. When the system is
assembled, the surgeon controls the footswitch; this
modifies the electrical signal to the motor, controlling
the speed of the cutting accessory. | Stryker's Precision Thin Reciprocating Blade, 0.010in.
is used in conjunction with an electric motor (CORETM
Reciprocating Saws), a CORETM Console and a
footswitch. When the system is assembled, the
surgeon controls the footswitch or handswitch; this
modifies the electrical signal to the motor, controlling
the speed of the cutting accessory. | Identical |
| Motor power supply | Powered by Electrical energy. | Electrical energy. | Identical |
| For use with a surgical
drill (handpiece) per 21
CFR 874.4140 | Legally marketed micro reciprocating blades - listed
under FDA product code EQJ (ENT Bur) are used with
the CORETM Reciprocating Saws. | Used with the CORETM Reciprocating Saws as
indicated on the product label. | Identical |
| Source of Activation | Footswitch and Handswitch. | Footswitch and Handswitch. | Identical |
| Feature | Subject Device: Precision Thin
Reciprocating Blade, 0.010in. | Device:
Anspach
Reference
Micro Reciprocating Saw Blade
(MR-0580) | Justification |
| Cutting Accessory
Locking Mechanism | Plug
Blade
locking
Tip
and
mechanism. | Chuck is tightened around shank. | Similar |
| Shank of the Cutting
Accessory | 0.125 - 0.124 inches | 0.124 inches | Identical |
| Cutting Accessory
Geometry | Cut Edge: 0.766 in. (19.5mm)
Blade Height: 0.137 in.
Cut Thickness: 0.010 in. | Cut Edge: 21.35 mm (0.84 in)
Cut Thickness: 0.25 mm (0.010 in) | Similar |
| Cutting Accessory
Length of exposure | 1.42 in. | 1.37 in. | Similar |
| Patient Contacting
Material | Blade Arbor - Stainless Steel | Blade Arbor - Stainless Steel. | Similar |
| | Blade - Stainless Steel
Vacuum Brazing Paste - NICROBRAZ
51 S ALLOY. | Blade - Stainless Steel.
Vacuum Brazing Paste - Unknown. | |
| Sterilization | Supplied sterile, gamma irradiated. | Supplied sterile, gamma irradiated. | Identical |
| Sterility Assurance
Level (SAL) | SAL of 10-6 | Minimum SAL of 10-6 | Identical |
| Shelf-Life | 5 Years | Unknown | Similar |
| Packaging
Configuration | Individually packaged in foil pouch with
Polybag. | Tyvek / Film pouch with the internal
packaging being a PETG clamshell
blister. | Similar |
8
Table 5-3: Comparative Device Justification Table.
9
Section 5.8 Performance Data
The following verification tests were performed which demonstrates that the device meets the performance requirements under its indications for use conditions.
- Kerf Width Testing ●
- Life, Simulated Use Testing ●
- Temperature Testing ●
Simulated use of a canal wall reconstruction was completed with 3 ENT surgeons for the specific indication in fresh cadaveric Human temporal bone. To supplement this cadaveric study design validation was also completed for the specific indication using PHACON's Temporal Bone Model with 8 ENT surgeons. This model was selected as a suitable cut media for design validation following a technical evaluation along with expert medical opinion. Collectively, the results of these performance tests demonstrate the functionality, integrity, safety and effectiveness of Stryker's Precision Thin Reciprocating Blade, 0.010in. for its intended use and support a determination of substantial equivalence to the regulation 21 CFR 874.4140 (ENT bur).
5.8.1 Biocompatibility Testing
The subject device Precision Thin Reciprocating Blade, 0.010in. is classified as external communicating device: tissue/bone/dentin with limited patient contact (