(18 days)
Not Found
No
The summary describes a simple electrosurgical accessory (cord and tubing set) with no mention of AI/ML capabilities or data processing.
No
The device is described as an "Integrated Tubing and Bipolar Cord Set" used to provide "irrigation and energy simultaneously to bipolar forceps." It interfaces with an irrigation unit and an electrosurgical generator. This functionality points to it being an accessory for surgical equipment (bipolar forceps, irrigation unit, electrosurgical generator), rather than a device that directly treats or diagnoses a medical condition itself.
No
Explanation: The device is described as an integrated tubing and bipolar cord set intended to provide irrigation and energy simultaneously to bipolar forceps. It facilitates a medical procedure rather than diagnosing a condition.
No
The device description explicitly states it is an "integrated irrigation tubing and electrical cord set" and the performance studies include extensive testing on physical components like biocompatibility, mechanical performance, electrical safety, sterilization, and packaging. This indicates it is a hardware device with physical components, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation." This describes a surgical or therapeutic procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "integrated irrigation tubing and electrical cord sets to be used with irrigating bipolar forceps." This further reinforces its role in a surgical or therapeutic setting.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly designed to facilitate a surgical procedure by providing irrigation and electrical energy to a surgical instrument.
N/A
Intended Use / Indications 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.
Product codes
GEI
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".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
The following summary of V&V Testing is provided to establish substantial equivalence.
Biocompatibility
- Cytotoxicity (MEM Elution): 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 Mediated Pyrogenicity: ISO 10993-11:2006, Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
- Irritation/Intracutaneous Reactivity: ISO 10993-10: 2010 Standard, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization.
- Sensitization (Guinea Pig Maximization): ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Skin Sensitization.
- Cytotoxicity (MEM Elution) after 2X sterilization: ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity
Mechanical and Performance Testing
- Functional Testing of Cord & Tube Set: Functional Testing of Cord & Tube Set after Packaging Testing 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 Test Report:
- 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 and Tests (Edition 3)
- ANSI/AAMI IEC 60601-2-2:2009, Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgery Equipment and High Frequency Surgical Accessories
Sterilization Validation
- 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.
Packaging Design Verification Testing
- T=0 Design Verification: ASTM D4169, Standard Test Method for Performance Testing of Shipping Containers and Systems
- T=1.5 Year Accelerated Aging 60C: ASTM F1886/F1886M, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
- T=3 Year Accelerated Aging 60C: ASTM F2096, Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization
- ASTM F88-15, Standard Test Method for Seal Strength of Flexible Barrier Materials
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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 Instruments |
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| Contact: | Susanne Galin |
| Principal Regulatory Affairs Specialist | |
| Stryker Instruments | |
| 4100 E. Milham Avenue | |
| Kalamazoo, MI 49001 | |
| Desk Phone +1 269 389 4132 | |
| Cell Phone +1 812 345 7917 | |
| Email: 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".
4
| 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:
| Technological
Characteristic | Integrated Tubing &
Bipolar Cord Set (as
cleared in K890648) | Currently Marketed Gravity Tubing & Bipolar
Cord Set | |
|-----------------------------------|--------------------------------------------------------------------|---------------------------------------------------------|------------------------------------------------|
| | | Gravity-type | Rotary-type |
| Electrical Cord
Length | 12 ft bipolar electrical cord | 10.958 ft ± 0.375 ft | 10.958 ft ± 0.375 ft |
| Lead type | flying leads | flying leads and unitized
leads | flying leads and unitized
leads |
| Electrical Cord
Connector | Female connector which
connects to forceps | Female connector which
connects to forceps | Female connector which
connects to forceps |
| Irrigation
Tubing Length | Total Length: 15 ft
irrigation tubing | Total length: 15.833 ft
(nominal) | Total Length: 15.583 ft
(nominal) |
| | 8.5 inch section serves as
pump chamber | 8.5 inch serves as pump
chamber | 5.5 inch serves as pump
chamber |
| Irrigation
Tubing
Connector | Spike with drip chamber | Spike with no drip
chamber | Spike with no drip
chamber |
| | Male Luer connects to
forceps (tubing) | Male Luer connects to
forceps (tubing) | Male Luer connects to
forceps (tubing) |
| Materials | Silicone tubing – Pump
PVC tubing - bag | Silicone tubing – Pump
PVC tubing - Bag | Silicone tubing – Pump
PVC tubing - Bag |
| Silicone tubing
wall 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" |
5
| Technological
Characteristic | Integrated Tubing &
Bipolar Cord Set (as
cleared in K890648) | Currently Marketed Gravity Tubing & Bipolar
Cord Set | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | | Gravity-type | Rotary-type |
| Packaging | Peel pouch, Mylar to Tyvek | Poly bag inside a peel-
pouch (60GA BIAX
Nylon/2.0 MIL LDPE,
Uncoated Tyvek 1073B) | Poly bag inside a peel-
pouch (60GA BIAX
Nylon/2.0 MIL LDPE,
Uncoated Tyvek 1073B) |
| Sterilization
Method | EtO | EtO | EtO |
| Sterilization
Parameters | 120° F Temperature
50° F Relative Humidity
750 Mgs. Per liter of Pure
EtO
3 hr Gas Exposure
2 Air washes | 130° F Temperature
Humidity Dwell: 30 min at
4.0"HgA
790 Mg/L 100% EtO
6 hrs 1 min gas exposure
2 Air/nitrogen/steam
washes | 130° F Temperature
Humidity Dwell: 30 min
at 4.0"HgA
790 Mg/L 100% EtO
6 hrs 1 min gas exposure
2 Air/nitrogen/steam
washes |
| 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 (MEM | |
| Elution) | 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 Mediated | |
| Pyrogenicity | ISO 10993-11:2006, Biological Evaluation of Medical Devices, Part 11: |
| Tests for Systemic Toxicity. | |
| Irritation/Intracutaneous | |
| Reactivity | ISO 10993-10: 2010 Standard, Biological Evaluation of |
| Medical Devices, Part 10: Tests for Irritation and Skin Sensitization. | |
| Sensitization (Guinea Pig | |
| Maximization) | ISO 10993-10:2010. Biological Evaluation of Medical Devices, Part 10: |
| Tests for Irritation and Skin Sensitization. | |
| Cytotoxicity (MEM | |
| Elution) after 2X | |
| sterilization | ISO 10993-5:2009 Biological Evaluation of Medical Devices, Part 5: |
| Tests for In Vitro Cytotoxicity |
6
| Mechanical and Performance Testing | |
|---|---|
| Functional Testing of | |
| Cord & Tube Set | Functional Testing of Cord & Tube Set after Packaging Testing |
| Testing 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 Test | |
| Report | 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 and | |
| Tests (Edition 3) | |
| ANSI/AAMI IEC 60601-2-2:2009, Medical Electrical Equipment – Part | |
| 2-2: Particular Requirements for the Basic Safety and Essential | |
| Performance of High Frequency Surgery Equipment and High Frequency | |
| Surgical Accessories | |
| Sterilization Validation | |
| 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. | |
| Packaging Design Verification Testing | |
| T=0 Design Verification | ASTM D4169, Standard Test Method for |
| Performance Testing of Shipping Containers and Systems | |
| T=1.5 Year Accelerated | |
| Aging 60C | ASTM F1886/F1886M, Standard Test Method for Determining Integrity |
| of Seals for Flexible Packaging by Visual Inspection | |
| T=3 Year Accelerated | |
| Aging 60C | ASTM F2096, Standard Test Method for Detecting |
| Gross Leaks in Porous Medical Packaging by Internal Pressurization | |
| ASTM F88-15, Standard Test Method for Seal Strength of Flexible | |
| Barrier Materials |
7
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.