(89 days)
The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.
The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.
The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue.
The Flex™ Endoscopic Instruments are electrosurgical and non-powered endoscopic instruments for use in endoscopic surgical procedures for tissue manipulation, dissection, cutting, and coagulation. The product family includes a Monopolar Maryland Dissector, Monopolar Needle Knife, Monopolar Spatula, Needle Driver, Fenestrated Grasper, Monopolar Scissor, and Laser Fiber Holder.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional and Durability Testing: Device function and durability for intended use. | "Bench testing... was performed to evaluate device function and durability. Mechanical testing and simulated use testing was conducted to confirm that the device has the necessary mechanical performance for its intended use." - Acceptable |
| Dimensional Verification: Device dimensions meet specifications. | "Dimensional verification was performed to confirm that the device dimensions are as specified." - Acceptable |
| Electrical Safety and EMC (IEC 60601-1, 60601-1-2, 60601-2-2): Compliance with relevant electrical safety and electromagnetic compatibility standards. | "Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with: IEC 60601-1: 2005 3d Edition; IEC 60601-1-2:2007; IEC 60601-2-2:2009. 5th Edition" - Acceptable |
| Biocompatibility (ISO 10993-1, 10993-5, 10993-10, 10993-11): Tissue contact materials are biocompatible. | "Biocompatibility testing was conducted according to the following ISO Standards: ISO 10993-1; ISO 10993-5:2009; ISO 10993-10:2002 (A1 :2006); ISO 10993-11:2006." "Tissue contact materials are biocompatible per ISO 10993" - Acceptable |
| Sterility Assurance Level: SAL of $10^{-6}$. | "$10^{-6}$" - Met |
| Device Locking Features: Ability to hold articulation position. | "Yes" - Met |
| Tip Rotation: 360-degree rotation. | "Yes, 360°" - Met |
| Shaft Rotation: 360-degree rotation. | "360°" - Met |
| Minimum Endoscopic Cannula Size: 4mm minimum. | "4 mm minimum" - Met |
| Electrosurgical Function (for monopolar devices): Yes, monopolar. | "Yes, monopolar" - Met |
| Generator Compatibility (where applicable): Compatible with monopolar generators (e.g., Covidien ForceTriad™ Energy Platform or equivalent). | "Monopolar generator e.g. Covidien ForceTriad™ Energy Platform or equivalent" - Met |
| Warnings, Cautions, and Contraindications: Stated in IFU. | "Stated in IFU" - Met |
| How Supplied: Sterile, single-use only. | "Sterile single use only" - Met |
Study Proving Acceptance Criteria:
The study conducted to prove the device meets acceptance criteria is a suite of nonclinical performance tests and analyses, rather than a single clinical trial. This includes:
- Bench Testing: Mechanical and simulated use testing to evaluate device function and durability.
- Dimensional Verification: To confirm the device dimensions.
- Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conducted in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.
The submission concludes that "Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" with a defined sample size in the context of the type of studies typically seen with AI algorithms or diagnostic devices. The tests performed are engineering evaluations (bench testing, dimensional, electrical, biocompatibility), which would involve a sample of manufactured devices or materials. The document does not provide the exact number of devices or material samples used for each specific test.
The data provenance is from laboratory and engineering testing conducted by the manufacturer, Design Standards Corporation. There is no indication of clinical data (e.g., country of origin, retrospective/prospective clinical studies) being used for this 510(k) submission, as it focuses on demonstrating technological equivalence to predicate devices through bench and material testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable for this type of submission. The "ground truth" for engineering and biocompatibility tests is established by adherence to recognized standards (e.g., IEC, ISO) and internal specifications, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting ambiguous cases, typically involving human readers. The tests performed here are objective engineering and laboratory tests with defined pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant for this Class II surgical instrument that relies on mechanical, electrical, and biocompatibility safety and performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone algorithm performance study was not done. This device is a physical surgical instrument, not a software algorithm that performs diagnostic or analytical functions independently.
7. Type of Ground Truth Used
The "ground truth" is based on:
- Engineering Specifications: For dimensional, functional, and durability tests.
- Defined Standards: For electrical safety (IEC standards) and biocompatibility (ISO standards).
- Predicate Device Characteristics: For demonstrating substantial equivalence.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission.
8. Sample Size for the Training Set
This information is not applicable. This device does not employ an AI algorithm or machine learning model that requires a training set. The "training set" concept is relevant for AI-powered devices, not for traditional surgical instruments.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as no training set was used.
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JUN 1 1 2014 K140662 Page 1 of 7
510(K) SUMMARY
Submitter Information
| Submitter's Name: | Design Standards Corporation |
|---|---|
| Address: | 957 Claremont RoadCharlestown, New Hampshire, 03603 |
| Telephone: | 603-826-7744 |
| Fax: | 603-826-4406933 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | May 19, 2014 |
| Device Trade Name: | Flex™ Endoscopic Instruments |
| Classification: | Class 2 |
| Product Code(s): | GCJ, GEI, GEX |
| Regulation Number(s): | 21 CFR 876.1500 Endoscope and Accessories |
| Predicate Device: | Covidien SILS™ and Endoscopic Hand Instruments(K091869, K951589, K914752) |
| Microsurge, Inc. Endoscopic Laser Fiber Holder(K912332) | |
| United States Surgical Corporation, Endoscopic NeedleDriver (K933725) |
Intended Use:
The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue. ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
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The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.
The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.
Device Description/Technological Characteristics:
The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue. The seven instruments are identified as follows
| FlexTM Endoscopic Instruments | ||
|---|---|---|
| Name | Catalog/REF # | Monopolar ElectrosurgicalYes or No |
| FlexTM Monopolar MarylandDissector | FXG0350D | Yes |
| FlexTM Monopolar Needle Knife | FXK0350M | Yes |
| FlexTM Monopolar Spatula | FXE0350M | Yes |
| FlexTM Needle Driver | FXN0350S | No |
| FlexTM Fenestrated Grasper | FXG0350F | No |
| FlexTM Monopolar Scissor | FXS0350M | Yes |
| FlexTM Laser Fiber Holder | FXL0350U | No |
Performance Data:
Bench testing of the Flex™ Monopolar instruments was performed to evaluate device function and durability. Mechanical testing and simulated use testing was conducted to confirm that the device has the necessary mechanical performance for its intended use.
Dimensional verification was performed to confirm that the device dimensions are as specified.
Electrical safety and Electromagnetic Compatibility testing was conducted in accordance with:
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IEC 60601-1: 2005 3d Edition: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2007, Medical Electrical Equipment -Part 1-2: General Requirements for Safety Collateral Standard Electromagnetic Compatibility Requirements and Tests.
IEC 60601-2-2:2009. 5th Edition, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
Biocompatibility testing was conducted according to the following ISO Standards:
ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process
ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity.
ISISO 10993-10:2002 (A1 :2006), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use.
Substantial Equivalence:
Flex™ Endoscopic Surgical Instruments and the predicate devices identified above have the same intended use and similar indications, technological characteristics, and principals of operation. A comparison chart is provided to illustrate substantial equivalence.
| Substantial Equivalence Comparison Chart | |||||
|---|---|---|---|---|---|
| Feature/Specification | Flex™Instruments | Covidien SILSandEndoscopic | MicrosurgeLaser FiberHolder | United StatesSurgicalCorporation | Comparison |
| Instruments | EndoscopicNeedle· Driver | ||||
| RegulatoryClearance/ApprovalReference | NA | K091869,K951589,K914752 | K912332 | 933725 | NA |
| Product Code | GCJ, GEI | GCJ, GEI | GEX | GCJ | Same |
| RegulationNumber | 21 CFR876.1500 | 21 CFR876.1500 | 21 CFR876.4810 | 21 CFR876.1500 | Same |
| RegulationName | Endoscope andaccessories | Endoscope andaccessories | Endoscopeandaccessories | Endoscopeandaccessories | Same |
| Substantial Equivalence Comparison Chart | |||||
| Feature/Specification | Flex™Instruments | Covidien SILSandEndoscopicInstruments | MicrosurgeLaser FiberHolder | United StatesSurgicalCorporationEndoscopicNeedleDriver | Comparison |
| Where used(environment) | Endoscopicsurgicalprocedures | Endoscopicsurgicalprocedures | Endoscopicsurgicalprocedures | Endoscopicsurgicalprocedures | Same |
| Handle design | Pistol Grip orWand | Pistol Grip | Wand | Pistol Grip | Same |
| ArticulatingFeature | Yes, ~90° | Yes, ~80° | No | No | Similar withonly minordifferences inthe articulationrange |
| Tip rotation | Yes, 360° | Yes, 360° | NA | Yes | Same |
| ManualOperation forrotation andarticulation | Yes | Yes | NA | NA | Same |
| Instrument types | Graspers,dissectors,scissors, needleknife, needleholder, laserfiber holder | Graspers,dissectors,scissors, L-hook knife | Laser FiberHolder | EndoscopicNeedle Driver | Similar, theneedle knifefunction issimilar to the L-Hook, the laserholder hassimilar designto the needleknife but is notanelectrosurgicaldevice andsimply holds thelaser fiber forsafeintroduction.The needleholder is similarto the graspersand dissectorbut is not anelectrosurgicaldevice. Thesedifferences donot introducenew concerns |
| Page 5 o | |||||
| Substantial Equivalence Comparison Chart | |||||
| Feature/Specification | Flex™Instruments | Covidien SILSandEndoscopicInstruments | MicrosurgeLaser FiberHolder | United StatesSurgicalCorporationEndoscopicNeedleDriver | Comparison |
| regarding safetyandperformance. | |||||
| Device lockingfeatures to holdarticulationposition | Yes | Yes | NA | NA | Same |
| Minimumendoscopiccannula size | 4 mmminimum | 5 mm | Unknown | Unknown | Same |
| ElectrosurgicalFunction | Yes,monopolar | Yes,monopolar | NA | NA | Same |
| Insertable shaftlength | 54 cm (rigidplus flexible) | 36 ad 46 cm | Unknown | Unknown | Minordifference ininsertion length.Thesedifferences donot introducenew concernsregarding safetyandperformance. |
| Shaft Diameter | 3.5 mm flexiblesection8 mm rigidsection | Various from~5-15 mm | Unknown | Unknown | Similar, therange for theFlex™instruments ismore or lesswithin the rangefor the predicatedevice. |
| Shaft flexibility | Flexiblethroughout 31cm length | Flexible atshaft tip | NA | NA | Similar, bothhave flexibleshaft portions.The Flex™design canaccommodate ashaped orflexible cannulain addition to arigid straightcannula. |
| Substantial Equivalence Comparison Chart | |||||
| Feature/Specification | Flex™Instruments | Covidien SILSandEndoscopicInstruments | MicrosurgeLaser FiberHolder | United StatesSurgicalCorporationEndoscopicNeedleDriver | Comparison |
| Otherwisefunction is thesame. Thesedifferences donot introducenew concernsregarding safetyandperformance. | |||||
| Shaft rotation | 360° | 360° | NA | 360° | Same |
| How Supplied | Sterile singleuse only | Sterile singleuse only | Sterile singleuse only | Sterile singleuse only | Same |
| Tissue ContactMaterials | Stainless steel,polymers,tungstenbrazing,adhesives,lubricant, padprinting ink | Generally:Stainless steel,polymers,adhesives, padprinting ink | Generally:Stainlesssteel,polymers,adhesives,pad printingink | Generally:Stainlesssteel,polymers,adhesives,pad printingink | Similar, thoughdifferences mayexists. Alltissue contactmaterials in theFlex™Instrumentswere evaluatedforbiocompatibility |
| Biocompatibility | Tissue contactmaterials arebiocompatibleper ISO 10993 | Tissue contactmaterials arebiocompatibleper ISO 10993 | Tissuecontactmaterials arebiocompatibleper ISO10993 | Tissuecontactmaterials arebiocompatibleper ISO10993 | Same |
| Electrosurgicalsafety | Complies withIECrequirementsfor electricalsafety andelectromagneticcompatibility | Complies withIECrequirementsfor electricalsafety andelectromagneticcompatibility | NA | NA | Same |
| Generatorcompatibility(whereapplicable) | Monopolargenerator e.g.CovidienForceTriad™EnergyPlatform or | Monopolargenerator e.g.CovidienForceTriad™EnergyPlatform or | NA | NA | Same |
| Feature/Specification | Flex™Instruments | Covidien SILSandEndoscopicInstruments | MicrosurgeLaser FiberHolder | United StatesSurgicalCorporationEndoscopicNeedleDriver | Comparison |
| equivalent | equivalent | ||||
| Warnings,cautions, andcontraindications | Stated in IFU | Stated in IFU | Stated in IFU | Stated in IFU | Statements aresimilar for boththe subject andpredicatedevices |
| Providedpackaged sterile,single use only | Yes | Yes | Unknown | Unknown | Same |
| Sterilization | Gamma | Ethylene Oxide | Unknown | Unknown | Same |
| SterilityAssurance Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | Same |
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K140662
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K140662 Page 6 of 7
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K140662 Page 7 of 7
The differences between the subject device and the predicate device include minor differences in dimensional characteristics and functional characteristics such as the degree of articulation, length and diameters. The Flex™ Instrument product offering includes a needle driver and a laser fiber holder. These are non-active devices and have similar device features as the rest of the product offering and fall under the general category of endoscopic surgical instruments. Predicate devices have been identified for each. Testing conducted on the Flex™ Instruments demonstrate the safety and performance of these devices for their intended use, further supporting that the differences noted compared to the predicate do not raise new questions of safety and efficacy. The Flex™ Endoscopic Instruments are substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 11, 2014
Design Standards Corporation Ms. Michele Lucey 957 Claremont Road Charlestown, New Hampshire 03603
Re: K140662
Trade/Device Name: Device Name: Flex™ Endoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ, GEI, GEX Dated: March 13, 2014 Received: March 19, 2014
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Image /page/7/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center is a stylized image of an eagle or other bird-like figure.
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Page 2 - Ms. Michele Lucey
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
David Krause -S
- 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140662
Device Name
Device Name: Flex™ Endoscopic Instruments
Indications for Use (Describe)
The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in encedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in encedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.
The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.
The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.
The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY | LAND LE ONLY | 1 1 1 1 1 1 ートの無料など、その他用品になる。 Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.