(18 days)
The Stryker Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
The subject devices are the Integrated Tubing and Bipolar Cord Sets. They are integrated irrigation tubing and electrical cord sets to be used with irrigating bipolar forceps, and interface with both the irrigation unit and the electrosurgical generator.
There are two types of sets available from Stryker: one type that is for use with a rotary irrigator unit and one type that is for use with a gravity irrigation unit. Additionally, each type is available with either "flying leads" or a "unitized lead".
This document describes the Stryker Integrated Bipolar Cord and Tubing Sets and their substantial equivalence to a predicate device. The information provided is primarily focused on the device's technical specifications, design principles, and validation tests to demonstrate its safety and performance. However, it does not involve a study showing how a device meets acceptance criteria in the context of diagnostic accuracy, human performance improvement with AI, or standalone algorithm performance, as often found in AI/ML medical device submissions.
Therefore, many of the requested categories are not applicable (N/A) because this is a 510(k) summary for an electrosurgical accessory, not a diagnostic or AI-powered device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) typically seen for diagnostic devices. Instead, it details various Verification and Validation (V&V) Testing conducted to ensure the device performs as intended and is safe. The "acceptance criteria" here are implied by the successful completion and passing of these standard tests. The "reported device performance" is that the device passed these tests, indicating it met the underlying requirements for each test.
| Category | Acceptance Criteria (Implied by Test Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Must meet the requirements of relevant ISO 10993 standards for: | The device passed all listed biocompatibility tests (Cytotoxicity, Systemic Toxicity, Material Mediated Pyrogenicity, Irritation/Intracutaneous Reactivity, Sensitization, and repeat Cytotoxicity after 2X sterilization), demonstrating it is biocompatible as per the standards. |
| Cytotoxicity (MEM Elution) | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | Passed |
| Systemic Toxicity | ISO 10993-11: 2006 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity | Passed |
| Material Mediated Pyrogenicity | ISO 10993-11:2006, Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity. | Passed |
| Irritation/Intracutaneous Reactivity | ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Passed |
| Sensitization (Guinea Pig Maximization) | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | Passed |
| Cytotoxicity (MEM Elution) after 2X sterilization | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity | Passed |
| Mechanical and Performance Testing | Must maintain functional integrity and meet specified performance parameters after various conditions (unaged, accelerated aged). Durometer, PSI levels, and overall functional performance must be within acceptable limits. | The device passed Functional Testing of Cord & Tube Set (unaged, 1.5 years accelerated aged, 3 years accelerated aged), Cord Set Durometer Testing, and Verification PSI Level Testing, confirming mechanical and performance integrity. |
| Functional Testing of Cord & Tube Set | Device remains functional after packaging testing and after accelerated aging (1.5 years and 3 years). | Passed (for unaged, 1.5 yrs, and 3 yrs accelerated aged samples) |
| Cord Set Durometer Testing | Within acceptable hardness range. | Passed |
| Verification PSI Level Testing (Rotary) | Specific pressure integrity for the rotary disposable cable with tubing. | Passed |
| Electrical Safety Testing | Must meet the requirements of relevant ANSI/AAMI IEC 60601 standards for general safety, essential performance, electromagnetic compatibility, and particular requirements for high-frequency surgical equipment. | The device passed Electrical Safety Tests, demonstrating compliance with ANSI/AAMI ES60601-1:2005, ANSI/AAMI IEC 60601-1-2:2007(R)2012, and ANSI/AAMI IEC 60601-2-2:2009. |
| Electrical Safety Test Report | Compliance with: - ANSI/AAMI ES60601-1:2005 (General Requirements for Basic Safety and Essential Performance)- ANSI/AAMI IEC 60601-1-2:2007(R)2012 (Electromagnetic Compatibility)- ANSI/AAMI IEC 60601-2-2:2009 (Particular Requirements for High Frequency Surgery Equipment) | Passed |
| Sterilization Validation | Must achieve a Sterility Assurance Level (SAL) of 10^-6 and comply with ANSI/AAMI/ISO 11135:2014 for Ethylene Oxide sterilization. | The device's sterilization validation demonstrated that it achieved a 10^-6 SAL in compliance with ANSI/AAMI/ISO 11135:2014. |
| Sterilization Validation | ANSI / AAMI / ISO 11135: 2014 Sterilization of health care products–Ethylene Oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices. | Passed (10^-6 SAL achieved) |
| Packaging Design Verification Testing | Packaging must protect the device during shipping and storage, maintaining package integrity and seal strength after accelerated aging. | The packaging passed T=0 Design Verification (shipping simulation), and integrity tests (visual inspection, gross leaks, seal strength) after 1.5 and 3 years of accelerated aging, demonstrating effective packaging. |
| T=0 Design Verification | ASTM D4169 (Performance Testing of Shipping Containers and Systems) | Passed |
| T=1.5 Year Accelerated Aging 60C | ASTM F1886/F1886M (Integrity of Seals for Flexible Packaging by Visual Inspection) | Passed |
| T=3 Year Accelerated Aging 60C | ASTM F2096 (Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization), ASTM F88-15 (Seal Strength of Flexible Barrier Materials) | Passed |
2. Sample Sizes Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each V&V test. These tests are typically conducted on a representative number of units according to the specific testing standards (e.g., ISO, ASTM, ANSI/AAMI), but the exact numbers are not detailed in this summary.
- Test Set Sample Size: Not explicitly stated for each test.
- Data Provenance: The data comes from internal testing and validation studies conducted by Stryker Instruments. The country of origin for the data is not specified but would typically be where Stryker conducts its R&D and manufacturing (e.g., USA). The studies are prospective in the sense that they are specifically designed and executed for regulatory submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
N/A. This device is an electrosurgical accessory, not a diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for these performance tests is defined by objective physical, electrical, and biological standards and measurements rather than expert consensus on medical images or patient conditions.
4. Adjudication Method for the Test Set
N/A. As explained above, there are no "interpretations" to adjudicate for device accessories. Acceptance is based on meeting objective physical/electrical/biological criteria.
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
N/A. This is not an AI/ML device, nor a diagnostic imaging interpretation device, so an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
N/A. This is not an algorithm-based device. It is a physical medical device (cord and tubing set).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests described is based on objective measurement standards defined by international and national organizations (ISO, ASTM, ANSI/AAMI). For example:
- Biocompatibility: Absence of cytotoxic effects, systemic toxicity, irritation, sensitization as per ISO standards.
- Electrical Safety: Compliance with specified electrical leakage currents, insulation resistance, and electromagnetic compatibility limits per ANSI/AAMI IEC 60601 standards.
- Mechanical Performance: Ability to withstand physical stresses, maintain specified dimensions (e.g., durometer readings), and pressure integrity.
- Sterilization: Achieving a 10^-6 Sterility Assurance Level as defined by ISO 11135.
- Packaging: Maintaining integrity against environmental and handling stresses as per ASTM standards.
8. The Sample Size for the Training Set
N/A. This device does not use a training set as it is not an AI/ML device. The "training" here refers to the design and development cycle, where engineers would iteratively design and test prototypes.
9. How the Ground Truth for the Training Set Was Established
N/A. As above, no "training set" in the context of AI/ML. The design and engineering "ground truth" is established through engineering specifications, design inputs derived from intended use, and existing regulatory standards for medical devices of this type.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles in a row.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2017
Stryker Instruments Ms. Susanne Galin Principal Regulatory Affairs Specialist 4100 E. Milham Avenue Kalamazoo, Michigan 49001
Re: K172367
Trade/Device Name: Stryker Integrated Bipolar Cord and Tubing Sets Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: August 2, 2017 Received: August 4, 2017
Dear Ms. Galin:
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 Actinclude 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 device
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related 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 (DICE) 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 (DICE) 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,
Jennifer R. Stevenson -S3
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) K172367
Device Name
Stryker Integrated Bipolar Cord and Tubing Sets
Indications for Use (Describe)
The Stryker Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
Type of Use (Select one or both, as applicable)
| Residential Real Estate (CRE) Sales or Financing | Other Transaction Not Involving CRE |
|---|---|
| ---------------------------------------------------------------- | --------------------------------------------------- |
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Stryker Integrated Bipolar Cord and Tubing Sets is provided below.
| Device Common Name: | Electrosurgical, Cutting & Coagulation & Accessories |
|---|---|
| Device Trade Name: | Stryker Integrated Bipolar Cord and Tubing Sets |
| Applicant: | Stryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001 |
| Contact: | Susanne GalinPrincipal Regulatory Affairs SpecialistStryker Instruments4100 E. Milham AvenueKalamazoo, MI 49001Desk Phone +1 269 389 4132Cell Phone +1 812 345 7917Email: susanne.galin@stryker.com |
| Date Prepared: | August 21, 2017 |
| Classification Regulation: | 21 CFR §878.4400- Electrosurgical, Cutting &Coagulation & Accessories, Class II |
| Panel: | General & Plastic Surgery |
| Product Code: | GEI - Electrosurgical, Cutting & Coagulation &Accessories |
| Predicate Device: | K890648, Malis Bipolar Cord/Irrigation Tubing Set |
Indication for Use:
The Stryker Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.
Device Description:
The subject devices are the Integrated Tubing and Bipolar Cord Sets. They are integrated irrigation tubing and electrical cord sets to be used with irrigating bipolar forceps, and interface with both the irrigation unit and the electrosurgical generator.
There are two types of sets available from Stryker: one type that is for use with a rotary irrigator unit and one type that is for use with a gravity irrigation unit. Additionally, each type is available with either "flying leads" or a "unitized lead".
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| Part Number | Item Name | Description |
|---|---|---|
| 6790-100-001 | Integrated Tubing and Bipolar Cord Set,Disposable | Gravity-type, flying lead. |
| 6790-100-002 | Integrated Tubing and Bipolar Cord Set,Disposable, Unitized Lead | Gravity-type, unitized lead. |
| 6790-100-003 | Bipolar Irrigator Integrated Tubing Set,Disposable | Rotary-type, flying lead. |
| 6790-100-004 | Bipolar Irrigator Integrated Tubing Set,Disposable, Unitized Plug | Rotary-type, unitized lead. |
Listing of Subject Devices
Device Comparison Table:
| TechnologicalCharacteristic | Integrated Tubing &Bipolar Cord Set (ascleared in K890648) | Currently Marketed Gravity Tubing & BipolarCord Set | |
|---|---|---|---|
| Gravity-type | Rotary-type | ||
| Electrical CordLength | 12 ft bipolar electrical cord | 10.958 ft ± 0.375 ft | 10.958 ft ± 0.375 ft |
| Lead type | flying leads | flying leads and unitizedleads | flying leads and unitizedleads |
| Electrical CordConnector | Female connector whichconnects to forceps | Female connector whichconnects to forceps | Female connector whichconnects to forceps |
| IrrigationTubing Length | Total Length: 15 ftirrigation tubing | Total length: 15.833 ft(nominal) | Total Length: 15.583 ft(nominal) |
| 8.5 inch section serves aspump chamber | 8.5 inch serves as pumpchamber | 5.5 inch serves as pumpchamber | |
| IrrigationTubingConnector | Spike with drip chamber | Spike with no dripchamber | Spike with no dripchamber |
| Male Luer connects toforceps (tubing) | Male Luer connects toforceps (tubing) | Male Luer connects toforceps (tubing) | |
| Materials | Silicone tubing – PumpPVC tubing - bag | Silicone tubing – PumpPVC tubing - Bag | Silicone tubing – PumpPVC tubing - Bag |
| Silicone tubingwall thickness | Not provided in K890648 | OD: 0.167" – 0.173"ID: 0.117" - 0.123" | OD: 0.117 (+0.008/-0.0)"ID: 0.028"- 0.035" |
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| TechnologicalCharacteristic | Integrated Tubing &Bipolar Cord Set (ascleared in K890648) | Currently Marketed Gravity Tubing & BipolarCord Set | |
|---|---|---|---|
| Gravity-type | Rotary-type | ||
| Packaging | Peel pouch, Mylar to Tyvek | Poly bag inside a peel-pouch (60GA BIAXNylon/2.0 MIL LDPE,Uncoated Tyvek 1073B) | Poly bag inside a peel-pouch (60GA BIAXNylon/2.0 MIL LDPE,Uncoated Tyvek 1073B) |
| SterilizationMethod | EtO | EtO | EtO |
| SterilizationParameters | 120° F Temperature50° F Relative Humidity750 Mgs. Per liter of PureEtO3 hr Gas Exposure2 Air washes | 130° F TemperatureHumidity Dwell: 30 min at4.0"HgA790 Mg/L 100% EtO6 hrs 1 min gas exposure2 Air/nitrogen/steamwashes | 130° F TemperatureHumidity Dwell: 30 minat 4.0"HgA790 Mg/L 100% EtO6 hrs 1 min gas exposure2 Air/nitrogen/steamwashes |
| SAL | 10-6 SAL | 10-6 SAL | 10-6 SAL |
| Shelf Life | Not provided in K890648 | 3 years | 3 years |
Performance Data:
The following summary of V&V Testing is provided to establish substantial equivalence.
| V&V Testing Summary | |
|---|---|
| Biocompatibility | |
| Cytotoxicity (MEMElution) | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5:Tests for In Vitro Cytotoxicity |
| Systemic Toxicity | ISO 10993-11: 2006 Biological Evaluation of Medical Devices Part 11:Tests for Systemic Toxicity |
| Material MediatedPyrogenicity | ISO 10993-11:2006, Biological Evaluation of Medical Devices, Part 11:Tests for Systemic Toxicity. |
| Irritation/IntracutaneousReactivity | ISO 10993-10: 2010 Standard, Biological Evaluation ofMedical Devices, Part 10: Tests for Irritation and Skin Sensitization. |
| Sensitization (Guinea PigMaximization) | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10:Tests for Irritation and Skin Sensitization. |
| Cytotoxicity (MEMElution) after 2Xsterilization | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5:Tests for In Vitro Cytotoxicity |
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| Mechanical and Performance Testing | |
|---|---|
| Functional Testing ofCord & Tube Set | Functional Testing of Cord & Tube Set after Packaging TestingTesting conducted on: |
| • Unaged Samples | |
| • Samples Accelerated Aged to 1.5 years | |
| • Samples Accelerated Aged to 3 years | |
| Cord Set Durometer Testing | |
| Verification PSI Level Testing for Disposable Cable with Tubing, Rotary | |
| Electrical Safety Testing | |
| Electrical Safety TestReport | ANSI/AAMI ES60601-1:2005, Medical Electrical Equipment – Part 1:General Requirements for Basic Safety and Essential Performance;Consolidated Reprint (2009); Amendment 2 (2010) |
| ANSI/AAMI IEC 60601-1-2:2007(R)2012, Medical Electrical Equipment –Part 1-2: General Requirements for Safety and Essential Performance –Collateral Standard : Electromagnetic Compatibility – Requirements andTests (Edition 3) | |
| ANSI/AAMI IEC 60601-2-2:2009, Medical Electrical Equipment – Part2-2: Particular Requirements for the Basic Safety and EssentialPerformance of High Frequency Surgery Equipment and High FrequencySurgical Accessories | |
| Sterilization Validation | |
| Sterilization Validation | ANSI / AAMI / ISO 11135: 2014 Sterilization of health care products–Ethylene Oxide-Requirements for the development, validation and routinecontrol of a sterilization process for medical devices. |
| Packaging Design Verification Testing | |
| T=0 Design Verification | ASTM D4169, Standard Test Method forPerformance Testing of Shipping Containers and Systems |
| T=1.5 Year AcceleratedAging 60C | ASTM F1886/F1886M, Standard Test Method for Determining Integrityof Seals for Flexible Packaging by Visual Inspection |
| T=3 Year AcceleratedAging 60C | ASTM F2096, Standard Test Method for DetectingGross Leaks in Porous Medical Packaging by Internal Pressurization |
| ASTM F88-15, Standard Test Method for Seal Strength of FlexibleBarrier Materials |
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Substantial Equivalence Conclusion:
As shown in the table above and evidenced by the Verification and Validation Activities described in the submission, the differences in technological characteristics between the currently marketed Integrated Tubing and Cord Sets and the versions cleared in K890648 do not raise new questions of safety and effectiveness, and can be found substantially equivalent.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.