(156 days)
The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.
This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.
The subject devices are made of ten (10) primary components which includes the following:
- Front Hub
- Overmolded Back Hub
- Disc Spring
- Yoke
- Yoke Pin
- Crimp Pin
- Short Blade
- Long Blade
- Surgislip Lubricant
- Heat Shrink with Adhesive Polymer
There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.
The subject devices are supplied as sterile. In accordance to 21 CFR § 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.
The provided text describes a 510(k) submission for an updated medical device, the "ReNew Laparoscopic Instruments Disposable Scissor Tips." This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on AI/ML performance.
The document discusses mechanical and biocompatibility testing for the updated scissor tips, mainly to show that design changes (related to the hub assembly and heat shrink) do not adversely affect performance or safety compared to the predicate device.
Therefore, the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI/ML test and training sets, expert ground truth establishment for AI/ML, MRMC studies, standalone AI performance, etc., cannot be extracted from this document as it is not an AI/ML medical device submission.
The document details the following:
1. Acceptance Criteria and Device Performance (Non-AI/ML):
The acceptance criteria are implicitly defined by the successful completion of various engineering and biological validation tests. The device performance is deemed acceptable if it meets these criteria, demonstrating equivalence to the predicate device and establishing safety and effectiveness.
| Acceptance Criteria Category (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Bench Performance Testing | Met performance specifications criteria for Substantial Equivalence. No new risks or safety/effectiveness issues raised. |
| Cutting Equivalency | Demonstrated equivalency to the currently marketed device. |
| Assembly and Disassembly | Successfully assembled and disassembled to the ReNew Handpiece. |
| Heat-shrink printing adhesion | Successfully demonstrated adhesion. |
| Tissue Thermal Spread | Tested and performance met requirements. |
| Ethylene Oxide (EO) Sterilization Validation | Validated. |
| Electrical Safety and EMC (IEC 60601-1, -1-2, -2-2) | Met requirements. |
| Biocompatibility (ISO 10993-1, -5, -10, -11) | Successfully established no new risks; determined to be biologically safe for Cytotoxicity, Intracutaneous Reactivity, Delayed type Sensitivity, Acute Systemic Toxicity, and Pyrogenicity. |
| Animal (Coagulation Performance) | Met all design and predetermined performance specifications to demonstrate intended use. |
2. Sample Size and Data Provenance (Non-AI/ML context):
- Sample sizes for testing: Specific numbers are not provided in this summary. The tests were "bench performance testing" and "animal testing." These typically involve a statistically relevant number of units to demonstrate consistency and reliability, but the exact N is not disclosed here.
- Data Provenance: Not explicitly stated as "country of origin" for testing data. The animal study was conducted in compliance with FDA Good Laboratory Practice Regulations.
3. Number of Experts and Qualifications:
Not applicable for this type of device submission as it does not involve human interpretation of AI outputs or image reading. The testing is primarily engineering and biological.
4. Adjudication Method:
Not applicable, as there's no AI output to adjudicate.
5. MRMC Comparative Effectiveness Study:
Not applicable. This is not an AI/ML device.
6. Standalone Performance Study:
Not applicable for a surgical instrument. The performance testing is integral to the device's function.
7. Type of Ground Truth:
For this device:
- Bench Performance: Performance specifications and engineering standards define the "ground truth" (e.g., successful cut, proper assembly, specified thermal spread).
- Biocompatibility: Established biological safety standards (ISO 10993 series) define the "ground truth" for material safety.
- Animal Testing: Pre-determined performance specifications observed in animal models established the "ground truth" for coagulation performance.
8. Sample Size for Training Set:
Not applicable. This is not an AI/ML device.
9. How Ground Truth for Training Set was Established:
Not applicable. This is not an AI/ML device.
In summary, the provided document is a 510(k) summary for a mechanical/electrosurgical device modification, not an AI/ML device. Therefore, the specific criteria and study details requested for an AI/ML device performance evaluation are not present in this document.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 2, 2022
Microline Surgical, Inc. Scott Davis Director, QA/RA 50 Dunham Road. Suite 1500 Beverly, Massachusetts 01915
Re: K213127
Trade/Device Name: ReNew Disposable Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 10, 2022 Received: January 26, 2022
Dear Scott Davis:
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 ffor 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (0S) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213127
Device Name
ReNew Laparoscopic Instruments Disposable Scissor Tips
Indications for Use (Describe) Indications for Use:
The ReNew single patient use disposable scissor tips are to be used with the ReNew
Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
| 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) ☐ |
|| | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Summary
[As Required by 21 CFR § 807.92]
I. SUBMITTER:
| Applicant: | Microline Surgical, Inc. 50 Dunham Road, Suite 1500 Beverly, MA 01915 USA |
|---|---|
| Establishment Registration Number: | 1223422 |
| Contact Representative: | Mr. Scott Marchand Davis Director, QA/RA Microline Surgical, Inc. Phone: 978-867-1758/Fax: 978-922-9209 Email: smarchanddavis@microlinesurgical.com |
| Date Prepared: | February 22, 2022 |
II. DEVICE:
| Device Trade or Proprietary Name: | ReNew Laparoscopic Instruments Disposable Scissor Tips |
|---|---|
| Common Name: | Manual Detachable Surgical Instruments |
| Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories |
| Regulation: | 21 CFR § 878.4400 |
| Classification: | Class II |
| Regulation Medical Specialty: | GEI |
| 510(k) Review Panel: | General and Plastic Surgery. |
| Accessories for Subject Device: | None. [This submission is for the Disposable Scissor Tips; the ReNew Handpiece, to which it attaches, is the subject of a separate 510(k) clearance] |
III. PREDICATE DEVICE:
III. PREDICATE DEVICE:
Predicate Device:
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"Re-New" Laparoscopic Instruments [510(k): K962119]
IV. DEVICE DESCRIPTION:
This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.
This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.
The subject devices are made of ten (10) primary components which includes the following:
- Front Hub ●
- Overmolded Back Hub ●
- Disc Spring ●
- Yoke
- Yoke Pin ●
- Crimp Pin
- Short Blade
- Long Blade ●
- Surgislip Lubricant ●
- Heat Shrink with Adhesive Polymer
There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.
The subject devices are supplied as sterile. In accordance to 21 CFR $ 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.
V. INDICATIONS FOR USE:
Device Name:
ReNew Laparoscopic Instruments Disposable Scissor Tips
Indications for Use:
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The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Contraindications:
The ReNew single patient use disposable scissor tips are not intended for use except as indicated.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
Overall, the subject devices, in comparison to their predicate device, are similar in the fundamental technology, intended use, and materials used in the method of construction. The primary differences between the predicate device and the subject include the following:
- Change from two-piece hub assembly to one-piece overmolded hub 1.
-
- Minor change to heat-shrink tubing to include an adhesive layer
To provide further detail, the current ReNew Disposable Scissor Hub Assembly requires that hub assemblies be created by screwing the front hub to the back hub and adding epoxy before they can be used on the automated assembly line. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub, which is done by an outside vendor. This eliminates the labor required of Microline employees to create the hub assembly. The new overmolded hub assembly does not have a threaded joint or epoxy. The updated front hub has a crisscross pattern that the back hub is overmolded on to. The predicate device back hub is made from PEEK and the subject device back hub is made from Radel. All appropriate testing has been performed on the Radel back hubs to ensure they meet requirements.
Due to the change to the hub design, an additional change needed to be made to the heat shrink on the scissor tip. The current heat shrink, MT5000, is made from polyolefin tubing. The updated heat shrink, MT5000A, is the same base material and has an inner polymer lining made of ELVAX 760, an ethylene vinyl acetate copolymer. The polymer layer acts as an adhesive for heat shrink. It melts as the polyolefin tubing shrinks, providing a seal to insulate and prevent passage of moisture.
| Characteristics | Predicate Device[510(k): K962119] | Subject Device[510(k): K213127] |
|---|---|---|
| Trade or Proprietary Name | "Re-New" LaparoscopicInstruments | ReNew LaparoscopicInstruments Disposable ScissorTips |
| 510(k) Number | K962119 | K213127 |
| 510(k) Clearance Date | August 9th, 1996 | Not Applicable |
| Classification | Class II21 CFR § 878.4400 | Class II21 CFR § 878.4400 |
| Classification Name | Electrosurgical, Cutting &Coagulation & Accessories | Electrosurgical, Cutting &Coagulation & Accessories |
| Classification Product Code | GEI | GEI |
The following table shows a comparison of the subject and predicate devices:
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| Common Name | Manual Detachable SurgicalInstruments | Manual Detachable SurgicalInstruments |
|---|---|---|
| Marketed Brand Name | ReNew Disposable Scissor Tips | ReNew Disposable Scissor Tips |
| Regulation MedicalSpecialty | General and Plastic Surgery | General and Plastic Surgery |
| Environment of Use | Hospital, Operating Room (OR) | Hospital, Operating Room (OR) |
| Intended Use | Indications for Use Statement:Endoscopic (inclusive oflaparoscopic) Surgical Procedures | Indications for UseStatement:The ReNew single patient usedisposable scissor tips are to beused with the ReNewLaparoscopic Hand Pieces andthey are indicated for cuttingand coagulation of tissue inendoscopic and laparoscopicsurgical procedures. |
| Contraindications:None listed | Contraindications:The ReNew single patient usedisposable scissor tips are notintended for use exceptas indicated.(The proposed changes reflectadditional clarification regarding usewith ReNew Laparoscopic InstrumentHandpieces based on classificationregulations and understood coagulationusage when connected to a legallymarketed Electrosurgicalunit/Radiofrequency generator. Testdata further supports such usage) | |
| Target Population(Major Surgical Discipline) | All Major Surgical disciplines.Primarily Laparoscopic/GeneralSurgery. | All Major Surgical disciplines.Primarily Laparoscopic/GeneralSurgery. |
| Technological Characteristics Comparison(Similarities and Differences) | ||
| Category | PredicateScissors | ModifiedScissors |
| Device Functionality | The ReNew single use disposablescissor tips are to be used with theReNew Laparoscopic Hand Piecesand they are indicated for cuttingand coagulation of tissue in | Identical |
| Principle of Operation | Cutting of tissue is a manualprocess achieved by using theReNew Disposable Scissor Tipwith a compatible ReNewLaparoscopic Handpiece.Coagulation is achieved byconnecting the handpiece to alegally marketed monopolarelectrosurgical generator (ESG). | Identical |
| Energy Source | Electrosurgical Generator | Identical |
| Energy Used and/ordelivered | High frequency monopolar | Identical |
| Method of Actuation | The scissor tips are actuated by theReNew handpiece | Identical |
| IEC Compliance Testing | IEC 60601-1: 2005 | IEC 60601-1 (3rd edition)IEC60601-1-2 (4th edition)IEC60601-2-2 (6th edition) |
| Mechanical Safety | Meets IEC 60601-1 safetyrequirements | Identical |
| Chemical Safety | Meets IEC 60601-1 safetyrequirements | Identical |
| Electrical Safety | Meets IEC 60601-1 safetyrequirements | IEC 60601-1 (3rd edition)IEC60601-1-2 (4th edition)IEC60601-2-2 (6th edition) |
| Thermal Safety | Meets IEC 60601-1 safetyrequirements | Identical |
| Radiation Safety | Meets IEC 60601-1 safetyrequirements | Identical |
| Device EnvironmentalCompatibility | Meets IEC 60601-1 safetyrequirements | Identical |
| Human FactorsEngineering/ UsabilityTesting | Meets IEC 60601-1 safetyrequirements | Meets IEC 60601-1 safetyrequirements including ISO62366 |
| Biological EvaluationTesting | Meets ISO 10993-1 requirements. | 10993-1: 201810993-5: 200910993-10: 201010993-11: 201710993-12: 2012 |
| Device Components | Front Hub• Back Hub (PEEK)• Epoxy• Disc Spring• Yoke• Yoke Pin• Crimp Pin• Short Blade | Front Hub• Overmolded Back Hub(Radel)• Disc Spring• Yoke• Yoke Pin• Crimp Pin• Short Blade |
| Long Blade Surgislip Lubricant Heat Shrink (MT5000) | Long Blade Surgislip Lubricant Heat Shrink with Adhesive Polymer (MT5000A) | |
| Dimensional Specifications(Endoccut Scissor) | Blade Length: 0.733 inThread Length: 0.489 inHeat Shrink - max diameter aftershrinking: 0.208 inHub Diameter: 0.203 in | Identical |
| Length(Assembly) | 2.327 Inches | Identical |
| Assembly | Epoxy used to attach front huband backhub. | Backhub overmolded on fronthub. Adhesive layer used onheat shrink tubing. |
| Materials(Patient Contact and Non-PatientContact) | The device primary componentsmaterials comparison and bloodcontact information is included inthe Section 12 for SubstantialEquivalence in this submission. | The device primary componentsmaterials comparison and bloodcontact information is includedin the Section 12 forSubstantial Equivalence in thissubmission. |
| Sterilization Method | Ethylene Oxide | Identical |
| Intended for Reuse | No | Identical |
| Sterile Barrier | Tyvek / LDPE Pouch | Tyvek/Nylon Pouch |
| Packaging | Solid Bleached Sulphate Box | Identical |
| Patient Contact | Yes | Yes |
| Blood/Fluid Contact | YesPrimary Blood/FluidComponent:Blades | YesPrimary Blood/FluidComponent:Blades |
| Shelf-Life/Usability | Single-Use | Identical |
| Special Conditions(Shipping and Handling) | No | No |
| Subject Device Manufacturing and Distribution | ||
| Business Type: | Address: | Address |
| Legal Manufacturer | Located at:Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USARegistration Number: 1223422 | Located at:Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USARegistration Number: 1223422 |
| (Brand Labeling and MarketDistribution) | Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USARegistration Number: 1223422 | Microline Surgical, Inc.50 Dunham Road, Suite 1500Beverly, MA 01915USARegistration Number: 1223422 |
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In comparison to their predicate device, the subject devices are identical in fundamental technology and intended use. The subject devices are supplied as sterile.
VII. PERFORMANCE DATA:
The subject device's performance characteristic testing requrements were assessed in accordance with the requirements set forth in 21 CFR § 820 for Quality System Regulation (QSR), under the FD&C Act, including current Good Manufacturing Practices (cGMP) requirements under this regulation and Microline Surgical, Inc. (hereafter referred to as MSI) internal procedures documented and applicable within the Corporate Quality System and Product Development procedures.
Bench performance testing was performed on the subject devices to establish that the subject devices meet the performance specifications criteria to determine Substantial Equivalence with their legally marketed predicate device. In accordance with design controls, the design verification testing was performed for the subject devices. The functional testing for the subject devices primarily included:
- Cutting equivalency to the currently marketed device
- Assembly and disassembly to the ReNew Handpiece ●
- Heat-shrink printing adhesion ●
- Tissue thermal spread ●
- Ethylene Oxide (EO) Sterilization Validation
- Electrical Safety and EMC testing per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 ●
Fundamentally, the subject device is Substantially Equivalent in fundamental technology and identical in intended use to its legally marketed predicate device. There were no new risks or safety, or effectiveness issues raised in the bench testing results. The subject devices are supplied as sterile.
Biocompatibility Testing:
Pursuant to ISO 10993-1:2009/AC: 2010 - Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process; 21 § CFR Part 58 - Good Laboratory Practice for Nonclinical Laboratory Studies; and FDA's Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management trovess", [issued on: June 16, 2016], which includes the FDA-modified matrix designating the type of testing for biological evaluation, the biological assessment of the subject devices was conducted.
The biological evaluation testing matrix included the following testing:
- Cytotoxicity (ISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity);
- Intracutaneous Reactivity, as recommended per, ISO 10993-10, Biologial waluation of medical O devices - Part 10: Tests for irritation and skin sensitization);
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- Delayed type Sensitivity, as recommended per, ISO 10993-10, Biological evaluation of medical o devices - Part 10: Tests for irritation and skin sensitization); and
- Acute Systemic Toxicity testing, as recommended per ISO 10993-11, Biological evaluation of O medical devices - Part 11: Tests for systemic toxicity).
- Pyrogenicity, as recommended per ISO 10993-11, Biological evaluation of medical devies Part 11: O Tests for systemic toxiity), to address the risks associated with the presence of chemical pyrogens in the material.
For the subject devices, biocompatibility testing successfully established that the subject devices did not raise any new risks, and that they were determined to be biologically safe.
Performance Testing - Animal:
Animal testing was performed to test the coagulation performance of the ReNew disposable tips with overmolded Radel backhubs and redesigned ReNew handpieces. The study was conducted in compliance with the Food and Drug Administration Good Laboratory Practice Regulations.
The nonclinical (animal) testing demonstrated that the subject devices met all the design and predetermined performance specifications to demonstrate their intended use.
VIII. SUBSTANTIAL EQUIVALANCE CONCLUSION:
Based upon the similarities in materials of construction, device design, performance, fundamental technology and the intended use, including the modifications to the design applicable to the subject devices, MSI has determined that the subject devices are deemed Substantially Equivalent to their legally marketed predicate device, "Re-New" Laparoscopic Instruments [510(k): K962119]. Similar to their predicate device, the subject devices are Class II devices per 21 CFR $ 878.4400, Product Code GEI, which under this classification category is identified as Electrosurgical, Cutting & Coagulation & Accessories. The predicate 510(k), K962119, was originally submitted for both the disposable scissor tips and the ReNew Handpiece. This new submission is solely for the disposable scissor tips. The ReNew Handpiece has been updated and cleared recently in submission K201884.
SUBSTANTIAL EQUIVALANCE STATEMENT:
The subject device does not raise new questions of safety and effectiveness and testing and evaluation demonstrates that it is at least as safe and effective as the legally marketed predicate, "Re-New" Laparoscopic Instruments [510(k): K962119].
§ 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.