(75 days)
Not Found
No
The device description and performance studies focus on the mechanical function and sterilization of a manually operated surgical instrument. There is no mention of AI or ML capabilities.
No
The device is a surgical instrument used for cutting bony tissue, not a therapeutic device designed to treat a disease or condition.
No
Explanation: The device is a surgical instrument (rongeur) designed for cutting bony tissue. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, manually operated surgical instrument with a handle and detachable tips designed for cutting bony tissue. The performance studies focus on physical attributes like cleaning, sterilization, cutting performance, durability, and corrosion resistance, all indicative of a hardware device. There is no mention of software components or functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "cutting bony tissue of the spine." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a manually operated instrument with a handle and tips designed for cutting bone. This aligns with a surgical tool, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical for surgical intervention.
IVD devices are used in vitro (outside the body) to examine specimens and provide information for diagnosis, monitoring, or screening. This device operates in vivo (within the body) during surgery.
N/A
Intended Use / Indications for Use
The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).
Product codes (comma separated list FDA assigned to the subject device)
HAE
Device Description
The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
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)
Design verification and validation testing including Performance sterilization for both the reusable and disposable components, Data cleaning for the reusable components, cutting performance, durability, shelf life (disposable tips), and corrosion resistance.
Validation of the recommended cleaning process for reusable components:
- Verification and Validation Activities: Cleaning challenge for reuse to confirm the device can be effectively cleaned.
- Acceptance Criteria: Cleaning validation results must meet the following criteria acceptance criteria: residual proteins, residual hemoglobin, and residual carbohydrates.
- Results: For substantial equivalence the device must be able to be adequately cleaned for reuse Pass.
- Device used for Testing: Symmetry Sharp Kerrison® Rongeur Handle (worst case).
Validation of the recommended steam sterilization cycles for reusable components:
- Verification and Validation Activities: Sterilization validation.
- Acceptance Criteria: Must meet the requirements as defined in the applicable ISO Standard for the overkill method to achieve an SAL of 10-6.
- Results: For substantial equivalence the reusable components must be able to be effectively sterilized with steam sterilization Pass.
- Device used for Testing: Symmetry Sharp Kerrison® Rongeur Handle (worst case).
Validation of gamma sterilization cycle for single use components:
- Verification and Validation Activities: Sterilization validation to confirm 10-6 SAL for gamma sterilization.
- Acceptance Criteria: Must meet the requirements as defined in the Applicable ISO standard for VDMax to achieve an SAL of 10-6.
- Results: For substantial equivalence the single use component must be able to be sterilized using gamma sterilization Pass.
- Device used for Testing: Symmetry Sharp Kerrison® Rongeur Tip.
Confirmation of multiple use for the reusable components:
- Verification and Validation Activities: Verification testing confirming performance for multiple uses.
- Acceptance Criteria: The detachable tips must maintain acceptable cutting performance for up to 100 cuts. Reusable handle must maintain performance for 50 reuse cycles.
- Results: For substantial equivalence the reusable must be sufficiently robust to support reuse Pass.
- Device used for Testing: Detachable Tips for the Symmetry Sharp Kerrison® Rongeur Handle And the Symmetry Sharp Kerrison® Rongeur Handle.
Resistance to corrosion for the reusable components:
- Verification and Validation Activities: Corrosion testing.
- Acceptance Criteria: Must not corrode when exposed to a corrosion challenge.
- Results: For Substantial Equivalence device must be resistant to corrosion Pass.
- Device used for Testing: Symmetry Sharp Kerrison® Rongeur Handle (same material as the reusable tips).
Packaging validation/shelf life for single use components:
- Verification and Validation Activities: Shelf Life studies per ASTM standards.
- Acceptance Criteria: Package and product must demonstrate package and product stability over the claimed shelf life period.
- Results: Package and product performance evaluations conducted on the single use component for shelf life confirm a two year shelf life Pass.
- Device used for Testing: Symmetry Sharp Kerrison® Rongeur Tip.
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
§ 882.4840 Manual rongeur.
(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 7, 2016
Symmetry Surgical Inc. % Ms. Michele Lucey Regulatory Consultant Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury. New Hampshire 03255
Re: K161744
Trade/Device Name: Symmetry Sharp Kerrison® Rongeur Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: August 6, 2016 Received: August 8, 2016
Dear Ms. Lucey:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Carlos L. Pena -5ி/Δ
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161744
Device Name Symmetry Sharp Kerrison® Rongeur
Indications for Use (Describe)
The Symmetry Sharp Kerrison Rongeur is indicated for cutting bony tissue of the Symmetry Sharp Kerrison Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).
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 D) |
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K161744
Symmetry Surgical Inc Special
510(k) Summary
This 510(k) Summary is submitted in accordance with the requirements of 21 CFR Part 807, Section 807.92(c)
Submitter Information:
| Submitter's
| Name: | Symmetry Surgical Inc. |
|---|---|
| Address: | 3034 Owen Drive, Antioch TN 37013 |
| Telephone: | 1-800-251-3000 |
| Fax: | 1-615-964-5567 |
| Submitter | |
| Regulatory | |
| Contact: | Michele Lucey |
| Lakeshore Medical Device Consulting, LLC | |
| 128 Blye Hill Landing | |
| Newbury, NH 03255 | |
| 603-763-3455 | |
| Date Prepared: | September 7, 2016 |
| Device Trade | |
| Name: | Symmetry Sharp Kerrison® Rongeur |
| Common/Usual | |
| Name: | Manual Rongeur |
| Regulation | |
| Name: | Manual Rongeur |
| Regulation | |
| Number: | 21 CFR 882.4840 |
4
| Class | 2 |
|---|---|
| Product Code | HAE |
| Predicate | |
| Device | K130541 Kerrison Disposable Tip Rongeur |
| Intended Use | The Symmetry Sharp Kerrison® Rongeur is indicated for cutting |
| bony tissue of the spine. The Symmetry Sharp Kerrison® | |
| Rongeur is a manually operated instrument that consists of a | |
| Handle and Tips (available in single use or reusable). | |
| Device | |
| Description | The Symmetry Sharp Kerrison Rongeur is designed to have |
| detachable tips that are disposable. The detachable tips are | |
| provided as either sterile single use or as nonsterile reusable tips. | |
| The reusable tips must be cleaned and sterilized before use. The | |
| sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 | |
| mm); which are identifiable by etchings on each device. The | |
| Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle | |
| are available in 3 cup sizes: (2, 3, and 4 mm); which are | |
| identifiable by etchings on each device. The reusable tips have a | |
| mating code etched on each pair to ensure that only matched pairs | |
| are used. Each tip is designed with a shaft key that fits into its | |
| mating slot on the detachable instrument handle. The tip has cups, | |
| one within the stationary footplate and the other within the upper | |
| sliding shaft, performing the cutting of the bony tissue in the spine | |
| area. The various cup sizes within the working tips provide the | |
| surgeon various cutting configurations needed for the different | |
| characteristics of the bony tissue within the spine. The Symmetry | |
| Sharp Kerrison® Rongeur Handle operates with a cup and ball | |
| assembly for smooth motion of the footplate when the handle is | |
| squeezed. The detachable, reusable instrument handles of this | |
| device are provided non-sterile and must be cleaned and sterilized | |
| prior to use. The instrument handles are available in three shaft | |
| lengths: (5, 6, and 7 inches). |
5
| Feature/Specification | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Symmetry Sharp Kerrison® | |||
| Rongeur | Symmetry Kerrison Disposable | ||
| Tip Rongeurs | Of Subject Device to | ||
| Predicate Device | |||
| K130541 | |||
| General Description | Manual Rongeur | Manual Rongeur | Same |
| Intended Use | The Symmetry Sharp | ||
| Kerrison® Rongeur is | |||
| indicated for cutting bony | |||
| tissue of the spine. The | |||
| Symmetry Sharp | |||
| Kerrison® | |||
| Rongeur is a manually | |||
| operated instrument that | |||
| consists of a Handle and | |||
| Tips (available in single | |||
| use or reusable). | The Rongeur (handle and | ||
| tip) is indicated for cutting | |||
| bony tissue of the spine. | |||
| The Symmetry Kerrison | |||
| Disposable Tip Rongeur is | |||
| a manually operated | |||
| instrument that consists of | |||
| handle and disposable | |||
| detachable tips. | Same, except for the | ||
| removal of "disposable" to | |||
| allow for a general tip | |||
| description | |||
| Device Size and Geometry | Tips are provided in 4 cup | ||
| sizes, 1,2, 3, and 4 mm. | |||
| Handle is provided in three | |||
| shaft lengths, 5, 6, and 7 | |||
| inches | Tips are provided in 4 cup | ||
| sizes, 1,2, 3, and 4 mm. | |||
| Handle is provided in three | |||
| shaft lengths, 5, 6, and 7 inches | Same, except for the 1mm | ||
| tip will not be marketed as | |||
| a reusable device | |||
| Materials | Tips are 420 stainless steel | ||
| Handle is primarily 420 | |||
| stainless steel with mating | |||
| component parts made from | |||
| Mating components are | |||
| manufactured with German | |||
| Stainless Steel 1.4301, 1.4310 | |||
| (equivalent to 304 SS, 303 SS, | |||
| and 301 SS, respectively) | Tips are 420 stainless steel with | ||
| an ABS insert | |||
| Handle is primarily 420 | |||
| stainless steel with mating | |||
| component parts made from | |||
| German Stainless Steel 1.4301, | |||
| 1.4310 (equivalent to 304 SS, | |||
| 303 SS, and 301 SS) | Same except for the | ||
| removal of the ABS insert | |||
| which had no mechanical | |||
| or performance function, no | |||
| longer present in the current | |||
| disposable tip | |||
| design | |||
| Mechanism of action | Cutting shaft and footplate | Cutting shaft and footplate | Same |
| Feature/Specification | Subject Device | Predicate Device | Comparison |
| Symmetry Sharp Kerrison® | |||
| Rongeur | Symmetry Kerrison Disposable | ||
| Tip Rongeurs | |||
| K130541 | Of Subject Device to | ||
| Predicate Device | |||
| closed on tissue through | |||
| mechanical handle | |||
| compression | closed on tissue through | ||
| mechanical handle compression | |||
| Limits of use | Reusable handle, disposable | ||
| tips, and reusable tips | Reusable handle and disposable | ||
| tips | Similar, both devices have | ||
| reusable and disposable | |||
| components | |||
| How Supplied | Disposable tips are sterile | ||
| Reusable tips and reusable | |||
| handle are nonsterile and must | |||
| be cleaned and sterilized | |||
| before first use | Disposable tips are sterile | ||
| Reusable handle is nonsterile | |||
| and must be cleaned and | |||
| sterilized before first use | Same, only difference is | ||
| inclusion of the reusable | |||
| tips | |||
| SAL | 10-6 | 10-6 | Same |
| Sterilization Method | Gamma for the disposable tips | ||
| Steam for the reusable handle | |||
| and disposable tips | Gamma for the disposable tips | ||
| Steam for the reusable handle | Same except for adding | ||
| steam for reusable tips |
Technological Characteristics of the Device Compared to the Predicate Device:
6
Principles of Operation:
Each tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the patient's spinal area when the instrument handles are compressed by the surgeon.
Design verification and validation testing including Performance sterilization for both the reusable and disposable components, Data cleaning for the reusable components, cutting performance, durability, shelf life (disposable tips), and corrosion resistance. The following table provides details relative to the device performance testing used to support substantial equivalence:
7
| Summary of Performance Testing Conducted to Establish Substantial Equivalence | ||||
|---|---|---|---|---|
| Performance Test | Verification and | |||
| Validation | ||||
| Activities | Acceptance Criteria | Results | Device used for | |
| Testing | ||||
| Validation of the | ||||
| recommended | ||||
| cleaning process | ||||
| for reusable | ||||
| components | Cleaning | |||
| challenge for | ||||
| reuse to confirm | ||||
| the device can | ||||
| be effectively | ||||
| cleaned. | Cleaning validation | |||
| results must meet the | ||||
| following criteria | ||||
| acceptance criteria: | ||||
| residual proteins | ||||
| residual hemoglobin | ||||
| and residual | ||||
| carbohydrates | For substantial | |||
| equivalence the | ||||
| device must be | ||||
| able to be | ||||
| adequately | ||||
| cleaned for reuse | ||||
| Pass | Symmetry Sharp | |||
| Kerrison® Rongeur | ||||
| Handle (worst case) | ||||
| Validation of | ||||
| the | ||||
| recommended | ||||
| steam | ||||
| sterilization | ||||
| cycles for | ||||
| reusable | ||||
| components | Sterilization | |||
| validation | Must meet the | |||
| requirements as | ||||
| defined in the | ||||
| applicable ISO | ||||
| Standard for the | ||||
| overkill method to | ||||
| achieve an SAL of 10-6 | For substantial | |||
| equivalence the | ||||
| reusable | ||||
| components | ||||
| must be able to | ||||
| be effectively | ||||
| sterilized with | ||||
| steam | ||||
| sterilization | ||||
| Pass | Symmetry Sharp | |||
| Kerrison® Rongeur | ||||
| Handle (worst case) | ||||
| Validation of | ||||
| gamma | ||||
| sterilization cycle | ||||
| for single use | ||||
| components | Sterilization | |||
| validation to | ||||
| confirm 10-6 | ||||
| SAL for | ||||
| gamma | ||||
| sterilization | Must meet the | |||
| requirements as | ||||
| defined in the | ||||
| Applicable ISO | ||||
| standard for VDMax to | ||||
| achieve an SAL of | ||||
| 10-6 | For substantial | |||
| equivalence the | ||||
| single use | ||||
| component must | ||||
| be able to be | ||||
| sterilized using | ||||
| gamma | ||||
| sterilization | ||||
| Pass | Symmetry Sharp | |||
| Kerrison® | ||||
| Rongeur Tip | ||||
| Confirmation of | ||||
| multiple use for | ||||
| the reusable | ||||
| components | Verification | |||
| testing | ||||
| confirming | ||||
| performance for | ||||
| multiple uses | The detachable tips | |||
| must maintain | ||||
| acceptable cutting | ||||
| performance for up to | ||||
| 100 cuts. | ||||
| Reusable handle must | ||||
| maintain performance | ||||
| for 50 reuse cycles | For substantial | |||
| equivalence the | ||||
| reusable must be | ||||
| sufficiently | ||||
| robust to support | ||||
| reuse | ||||
| Pass | Detachable Tips for | |||
| the Symmetry Sharp | ||||
| Kerrison® Rongeur | ||||
| Handle | ||||
| And the Symmetry | ||||
| Sharp Kerrison® | ||||
| Rongeur Handle | ||||
| Summary of Performance Testing Conducted to Establish Substantial Equivalence | ||||
| Performance Test | Verification and | |||
| Validation | ||||
| Activities | Acceptance Criteria | Results | Device used for | |
| Testing | ||||
| Resistance to | ||||
| corrosion for the | ||||
| reusable | ||||
| components | Corrosion | |||
| testing | Must not corrode | |||
| when exposed to a | ||||
| corrosion challenge | For Substantial | |||
| Equivalence | ||||
| device must be | ||||
| resistant to | ||||
| corrosion | ||||
| Pass | Symmetry Sharp | |||
| Kerrison® Rongeur | ||||
| Handle (same | ||||
| material as the | ||||
| reusable tips) | ||||
| Packaging | ||||
| validation/shelf | ||||
| life for single | ||||
| use components | Shelf Life | |||
| studies per | ||||
| ASTM | ||||
| standards | Package and product | |||
| must demonstrate | ||||
| package and product | ||||
| stability over the | ||||
| claimed shelf life | ||||
| period | Package and | |||
| product | ||||
| performance | ||||
| evaluations | ||||
| conducted on the | ||||
| single use | ||||
| component for | ||||
| shelf life confirm | ||||
| a two year shelf | ||||
| life | ||||
| Pass | Symmetry Sharp | |||
| Kerrison® | ||||
| Rongeur Tip |
8
Based on the performance testing and comparison the subject device
is substantially equivalent to the predicate. Conclusion: