(75 days)
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 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).
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the device "Symmetry Sharp Kerrison® Rongeur":
This document describes a medical device called the "Symmetry Sharp Kerrison® Rongeur," which is a manual rongeur used for cutting bony tissue of the spine. The information provided heavily emphasizes comparison to a predicate device (K130541 Kerrison Disposable Tip Rongeur) to establish substantial equivalence for FDA 510(k) clearance. The testing described primarily focuses on validating the safety and performance characteristics for a mechanical surgical instrument, not an AI/ML-driven device. Therefore, many standard questions related to AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) are not applicable or directly addressed in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|
| Cleaning Validation for Reusable Components | Residual proteins, residual hemoglobin, and residual carbohydrates must meet specified acceptance criteria. | "For substantial equivalence the device must be able to be adequately cleaned for reuse. Pass" (Indicates criteria were met) |
| Steam Sterilization Validation for Reusable Components | Must meet requirements in applicable ISO Standard for the overkill method to achieve an SAL (Sterility Assurance Level) of 10-6. | "For substantial equivalence the reusable components must be able to be effectively sterilized with steam sterilization. Pass" (Indicates criteria were met) |
| Gamma Sterilization Validation for Single-Use Components | Must meet requirements in 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" (Indicates criteria were met) |
| Confirmation of Multiple Use for Reusable Components (Durability) | 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" (Indicates criteria were met for both tips and handle as per the criteria) |
| Resistance to Corrosion for Reusable Components | Must not corrode when exposed to a corrosion challenge. | "For Substantial Equivalence device must be resistant to corrosion. Pass" (Indicates criteria were met) |
| Packaging Validation/Shelf Life for Single-Use Components | 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" (Indicates a 2-year shelf life was confirmed, meeting stability criteria) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test (e.g., number of rongeurs tested for cleaning, sterilization, or durability). It refers to standard validation activities but doesn't quantify the number of units or cycles performed for each test.
- Data Provenance: The studies are described as "Design verification and validation testing" which are prospective tests conducted by the manufacturer specifically for this submission. The origin (e.g., country) is not specified beyond the manufacturer's location (Antioch, TN, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided. The "ground truth" for a mechanical device like a rongeur is based on objective performance metrics (e.g., sterilization efficacy, cutting performance, corrosion resistance) measured against defined standards or engineering specifications, not expert consensus on interpretations.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a mechanical surgical instrument, not an AI/ML diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a mechanical surgical instrument.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for the performance tests relies on:
- Established Standards: Primarily ISO standards for sterilization (SAL of 10-6), ASTM standards for shelf life.
- Engineering Specifications: Criteria for residual proteins/hemoglobin/carbohydrates, number of cuts/reuse cycles for durability, and absence of corrosion. These are objective, measurable parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this mechanical device.
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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
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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
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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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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'sName: | Symmetry Surgical Inc. |
|---|---|
| Address: | 3034 Owen Drive, Antioch TN 37013 |
| Telephone: | 1-800-251-3000 |
| Fax: | 1-615-964-5567 |
| SubmitterRegulatoryContact: | Michele LuceyLakeshore Medical Device Consulting, LLC128 Blye Hill LandingNewbury, NH 03255603-763-3455 |
| Date Prepared: | September 7, 2016 |
| Device TradeName: | Symmetry Sharp Kerrison® Rongeur |
| Common/UsualName: | Manual Rongeur |
| RegulationName: | Manual Rongeur |
| RegulationNumber: | 21 CFR 882.4840 |
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| Class | 2 |
|---|---|
| Product Code | HAE |
| PredicateDevice | K130541 Kerrison Disposable Tip Rongeur |
| Intended Use | The Symmetry Sharp Kerrison® Rongeur is indicated for cuttingbony tissue of the spine. The Symmetry Sharp Kerrison®Rongeur is a manually operated instrument that consists of aHandle and Tips (available in single use or reusable). |
| DeviceDescription | The Symmetry Sharp Kerrison Rongeur is designed to havedetachable tips that are disposable. The detachable tips areprovided as either sterile single use or as nonsterile reusable tips.The reusable tips must be cleaned and sterilized before use. Thesterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4mm); which are identifiable by etchings on each device. TheReusable Tips for the Symmetry Sharp Kerrison® Rongeur Handleare available in 3 cup sizes: (2, 3, and 4 mm); which areidentifiable by etchings on each device. The reusable tips have amating code etched on each pair to ensure that only matched pairsare used. Each tip is designed with a shaft key that fits into itsmating slot on the detachable instrument handle. The tip has cups,one within the stationary footplate and the other within the uppersliding shaft, performing the cutting of the bony tissue in the spinearea. The various cup sizes within the working tips provide thesurgeon various cutting configurations needed for the differentcharacteristics of the bony tissue within the spine. The SymmetrySharp Kerrison® Rongeur Handle operates with a cup and ballassembly for smooth motion of the footplate when the handle issqueezed. The detachable, reusable instrument handles of thisdevice are provided non-sterile and must be cleaned and sterilizedprior to use. The instrument handles are available in three shaftlengths: (5, 6, and 7 inches). |
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| Feature/Specification | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Symmetry Sharp Kerrison®Rongeur | Symmetry Kerrison DisposableTip Rongeurs | Of Subject Device toPredicate Device | |
| K130541 | |||
| General Description | Manual Rongeur | Manual Rongeur | Same |
| Intended Use | The Symmetry SharpKerrison® Rongeur isindicated for cutting bonytissue of the spine. TheSymmetry SharpKerrison®Rongeur is a manuallyoperated instrument thatconsists of a Handle andTips (available in singleuse or reusable). | The Rongeur (handle andtip) is indicated for cuttingbony tissue of the spine.The Symmetry KerrisonDisposable Tip Rongeur isa manually operatedinstrument that consists ofhandle and disposabledetachable tips. | Same, except for theremoval of "disposable" toallow for a general tipdescription |
| Device Size and Geometry | Tips are provided in 4 cupsizes, 1,2, 3, and 4 mm.Handle is provided in threeshaft lengths, 5, 6, and 7inches | Tips are provided in 4 cupsizes, 1,2, 3, and 4 mm.Handle is provided in threeshaft lengths, 5, 6, and 7 inches | Same, except for the 1mmtip will not be marketed asa reusable device |
| Materials | Tips are 420 stainless steelHandle is primarily 420stainless steel with matingcomponent parts made fromMating components aremanufactured with GermanStainless Steel 1.4301, 1.4310(equivalent to 304 SS, 303 SS,and 301 SS, respectively) | Tips are 420 stainless steel withan ABS insertHandle is primarily 420stainless steel with matingcomponent parts made fromGerman Stainless Steel 1.4301,1.4310 (equivalent to 304 SS,303 SS, and 301 SS) | Same except for theremoval of the ABS insertwhich had no mechanicalor performance function, nolonger present in the currentdisposable tipdesign |
| 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 DisposableTip RongeursK130541 | Of Subject Device toPredicate Device | |
| closed on tissue throughmechanical handlecompression | closed on tissue throughmechanical handle compression | ||
| Limits of use | Reusable handle, disposabletips, and reusable tips | Reusable handle and disposabletips | Similar, both devices havereusable and disposablecomponents |
| How Supplied | Disposable tips are sterileReusable tips and reusablehandle are nonsterile and mustbe cleaned and sterilizedbefore first use | Disposable tips are sterileReusable handle is nonsterileand must be cleaned andsterilized before first use | Same, only difference isinclusion of the reusabletips |
| SAL | 10-6 | 10-6 | Same |
| Sterilization Method | Gamma for the disposable tipsSteam for the reusable handleand disposable tips | Gamma for the disposable tipsSteam for the reusable handle | Same except for addingsteam for reusable tips |
Technological Characteristics of the Device Compared to the Predicate Device:
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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:
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| Summary of Performance Testing Conducted to Establish Substantial Equivalence | ||||
|---|---|---|---|---|
| Performance Test | Verification andValidationActivities | Acceptance Criteria | Results | Device used forTesting |
| Validation of therecommendedcleaning processfor reusablecomponents | Cleaningchallenge forreuse to confirmthe device canbe effectivelycleaned. | Cleaning validationresults must meet thefollowing criteriaacceptance criteria:residual proteinsresidual hemoglobinand residualcarbohydrates | For substantialequivalence thedevice must beable to beadequatelycleaned for reusePass | Symmetry SharpKerrison® RongeurHandle (worst case) |
| Validation oftherecommendedsteamsterilizationcycles forreusablecomponents | Sterilizationvalidation | Must meet therequirements asdefined in theapplicable ISOStandard for theoverkill method toachieve an SAL of 10-6 | For substantialequivalence thereusablecomponentsmust be able tobe effectivelysterilized withsteamsterilizationPass | Symmetry SharpKerrison® RongeurHandle (worst case) |
| Validation ofgammasterilization cyclefor single usecomponents | Sterilizationvalidation toconfirm 10-6SAL forgammasterilization | Must meet therequirements asdefined in theApplicable ISOstandard for VDMax toachieve an SAL of10-6 | For substantialequivalence thesingle usecomponent mustbe able to besterilized usinggammasterilizationPass | Symmetry SharpKerrison®Rongeur Tip |
| Confirmation ofmultiple use forthe reusablecomponents | Verificationtestingconfirmingperformance formultiple uses | The detachable tipsmust maintainacceptable cuttingperformance for up to100 cuts.Reusable handle mustmaintain performancefor 50 reuse cycles | For substantialequivalence thereusable must besufficientlyrobust to supportreusePass | Detachable Tips forthe Symmetry SharpKerrison® RongeurHandleAnd the SymmetrySharp Kerrison®Rongeur Handle |
| Summary of Performance Testing Conducted to Establish Substantial Equivalence | ||||
| Performance Test | Verification andValidationActivities | Acceptance Criteria | Results | Device used forTesting |
| Resistance tocorrosion for thereusablecomponents | Corrosiontesting | Must not corrodewhen exposed to acorrosion challenge | For SubstantialEquivalencedevice must beresistant tocorrosionPass | Symmetry SharpKerrison® RongeurHandle (samematerial as thereusable tips) |
| Packagingvalidation/shelflife for singleuse components | Shelf Lifestudies perASTMstandards | Package and productmust demonstratepackage and productstability over theclaimed shelf lifeperiod | Package andproductperformanceevaluationsconducted on thesingle usecomponent forshelf life confirma two year shelflifePass | Symmetry SharpKerrison®Rongeur Tip |
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Based on the performance testing and comparison the subject device
is substantially equivalent to the predicate. Conclusion:
§ 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).