The ENABLE Endoscopic Bipolar Scissors are substantially equivalent to the CardioThoracic Systems. Symbiosis, Everest Medical and ENABLE Bipolar Scissors in that each consist of a handle which is connected to a pair of scissor blades with electrodes on each blade. All the devices utilize the same bipolar electrosurgical technology. i.e. radio frequency (RF) energy. 10 caurerize the blood vessels by heating proteins in the tissue to a temperature where the proteins congeal.

The ENABLE Endoscopic Bipolar Scissors contain both a negative and positive electrode on each blade. The function of the ENABLE and predicate devices is the same; current flows from a negatively charged pole through the tissue to a positively charged pole. The ENABLE, CardioThoracic. Symbiosis and Everest Bipolar Scissors are connected to a similar electrosurgical generator that supplies RF bipolar energy. The ENABLE. CardioThoracic and Everest Bipolar Scissors are all labeled for use with the Valleylab Force 2 Electrosurgical Generator or equivalent electrosurgical units. All four bipolar scissors listed in this notification are labeled for operation at a comparable range (15-35 watts). Labeling for the ENABLE Endoscopic Bipolar Scissors are provided with each product. As with other bipolar instruments. there is no need for a grounding pad for the return electrode, therefore. the current does not travel through the patient to the grounding pad as it does with monopolar instruments. Patient burns seen with monopolar devices due to electrical current passage are eliminated.

The ENABLE Endoscopic Bipolar Scissors and the listed predicate devices are of similar size with an overall length range of 33 to 48cm (13 to 19 inches) and a scissors blade length range of approximately 0.7 inches. The scissors shaft is designed to fit a standard 5mm cannula. The bipolar devices utilize similar materials of construction including stainless steel scissors blades. All of the materials utilized in the ENABLE Endoscopic Bipolar Scissors are standard medical device materials that are used in a variety of tissue contact medical devices.

AI/ML Overview

The provided 510(k) summary for the ENABLE Endoscopic Bipolar Scissors focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria. This type of submission relies on the device being similar enough to already approved devices that it doesn't require new clinical efficacy studies.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a dedicated study. Instead, it relies on demonstrating equivalence through:

Intended Use Equivalence: Stating the intended use is "substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors."
Technological Equivalence: Describing similar design (handle, scissor blades, electrodes), same bipolar electrosurgical technology (RF energy to cauterize), similar current flow mechanisms, compatible electrosurgical generators (Valleylab Force 2 or equivalent), comparable operating range (15-35 watts), and similar size and materials.
Compliance with Standards: Listing compliance with relevant industrial/international standards.

Acceptance Criterion (Inferred from Equivalence)	Reported Device Performance (Inferred from Description)
Intended Use: Cut and coagulate soft tissue during laparoscopic and general surgical procedures.	"substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors." Device is "intended to cut and control bleeding through coagulation during tissue and control bleeding through coagulation during surgical procedures."
Electrosurgical Technology: Utilize bipolar radio frequency (RF) energy for cauterization.	"All the devices utilize the same bipolar electrosurgical technology, i.e. radio frequency (RF) energy. 10 caurerize the blood vessels by heating proteins in the tissue to a temperature where the proteins congeal." "The ENABLE Endoscopic Bipolar Scissors contain both a negative and positive electrode on each blade. The function of the ENABLE and predicate devices is the same; current flows from a negatively charged pole through the tissue to a positively charged pole."
Compatibility with Electrosurgical Generators: Compatible with standard electrosurgical generators, specifically Valleylab Force 2 or equivalent.	"The ENABLE, CardioThoracic and Everest Bipolar Scissors are all labeled for use with the Valleylab Force 2 Electrosurgical Generator or equivalent electrosurgical units."
Operating Range (Power): Operable within a comparable power range to predicate devices.	"All four bipolar scissors listed in this notification are labeled for operation at a comparable range (15-35 watts)."
Safety - No Grounding Pad Required: Does not require a patient grounding pad, eliminating burns associated with monopolar devices.	"As with other bipolar instruments, there is no need for a grounding pad for the return electrode, therefore, the current does not travel through the patient to the grounding pad as it does with monopolar instruments. Patient burns seen with monopolar devices due to electrical current passage are eliminated."
Physical Dimensions: Similar overall length and blade length to predicate devices. The shaft fits a standard 5mm cannula.	"The ENABLE Endoscopic Bipolar Scissors and the listed predicate devices are of similar size with an overall length range of 33 to 48cm (13 to 19 inches) and a scissors blade length range of approximately 0.7 inches. The scissors shaft is designed to fit a standard 5mm cannula."
Materials of Construction: Utilizes standard medical device materials, including stainless steel for blades.	"The bipolar devices utilize similar materials of construction including stainless steel scissors blades. All of the materials utilized in the ENABLE Endoscopic Bipolar Scissors are standard medical device materials that are used in a variety of tissue contact medical devices."
Biological Safety: Biocompatible and meets relevant biological evaluation standards.	"ISO 10993/EN 30993 Biological Evaluation of Medical Devices" (The document states the device will meet this standard, indicating compliance as part of the manufacturing process rather than a study proving performance against it for this submission).
Sterilization & Packaging: Packaging for terminally sterilized medical devices and sterilization by gamma irradiation meet relevant standards.	"ISO 11607 Packaging for Terminally Sterilized Medical Devices" "ISO 11137 Sterilization of Health Care Products, Sterilization of Gamma Irradiation" (Similar to above, compliance with standards for manufacturing).
Electrical Safety & Performance: Meets standards for electrosurgical devices and safety of high-frequency surgical equipment.	"ANSI/AAMI HF18 Electrosurgical Devices" "IEC 60601-2-2/EN 60601-2-2 Medical Electrical Equipment: Particular Requirements for Safety of High Frequency Surgical Equipment" (Similar to above, compliance with standards for manufacturing).
Mechanical Performance (Scissors): Meets standard specifications for insert and non-insert surgical scissors (implies appropriate cutting action and durability, though specific performance metrics are not detailed).	"ASTM F1079 Standard Specification for Insert and Non-insert Surgical Scissors" (Similar to above, compliance with standards for manufacturing).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) submission is for substantial equivalence, not a clinical study involving a test set of data. The "testing" referred to is likely engineering verification and validation demonstrating compliance with the listed standards, rather than a clinical performance study. There are no patient data sets or provenance mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is not an AI/diagnostic device that requires expert ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no test set in the context of diagnostic performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or decision support system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical surgical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this submission is based on the established safety and effectiveness of its predicate devices and compliance with recognized industry standards for design, manufacturing, and general safety.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable.

Summary

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ENABLE Medical Corporation

Endoscopic 5100k)

Nov 2 4 1999

510(k) SUMMARY ENABLE ENDOSCOPIC BIPOLAR SCISSORS 510(k) NOTIFICATION K 992996

GENERAL INFORMATION

Manufacturer:	ENABLE Medical Corporation6345 Centre Park DriveWest Chester, OH 45069-3863(513) 755-7600(513) 755-7676Est. Reg. No. 1530251
Contact Person:	Mark L. Friedman. Ph.D.Vice President of Quality Assurance & Regulatory AffairsENABLE Medical Corporation
Date Prepared:	[to be added after 510(k) process]
DEVICE DESCRIPTION
Classification:	Class II
Trade Name:	ENABLE Endoscopic Bipolar Scissors
Generic/Common Name:	Electrosurgical cutting and coagulation device andaccessories21CFR878.4400

PREDICATED DEVICES

Symbiosis Bipolar Scissors (K950286 and K951387) し、
Everest Medical Bipolar Scissors (K945975 and K955001) 2.
CardioThoracic Systems MIDCAB/SVH Bipolar Scissors (K963930) 3.
ENABLE Medical Corporation Bipolar Scissors (K972558 and K981219) 4.

INTENDED USE

The ENABLE Endoscopic Bipolar Scissors intended use is substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors. I bipolar scissors described in this section cut and coagulate soft tissue through the use of .polar technology. The ENABLE Endoscopic Bipolar Scissors are intended for use during laparoscopic and general surgical procedures.

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P.05

PRODUCT DESCRIPTION

The ENABLE Endoscopic Bipolar Scissors will meet the following industrial/international standards.

ISO 10993/EN 30993	Biological Evaluation of Medical Devices
ISO 11607	Packaging for Terminally Sterilized Medical Devices
ISO 11137	Sterilization of Health Care Products, Sterilization ofGamma Irradiation
ANSI/AAMI HF18	Electrosurgical Devices
IEC 60601-2-2/EN 60601-2-2	Medical Electrical Equipment: ParticularRequirements for Safety of High FrequencySurgical Equipment
ASTM F1079	Standard Specification for Insert and Non-insertSurgical Scissors

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Nov-22-99 10:52A

ENABLE Medical Corporation

SUMMARY

As contained in this 510(k) summary, the ENABLE Endoscopic Bipolar Scissors are substantially equivalent to the predicate devices identified.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines extending from the bottom of the profiles, resembling a wave or a stylized bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

Mark L. Friedman, Ph.D. Vice President of Quality Assurance and Regulatory Affairs Enable Medical Corporation 6345 Centre Park Drive West Chester, Ohio 45069

Re: K992996

Trade Name: Endoscope Bipolar Scissors Regulatory Class: II Product Code: GEI Dated: August 31, 1999 Received: September 7, 1999

Dear Dr. Friedman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Food and Drug Administration 510(k) Notification - The Turbo 7000™ System September 3, 1999

K992994 510(k) Number: Device Name: The Turbo 7000™ System

Intended Use:

The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures.

Otology procedures would include:

mastoidectomy and ●
mastoidotomy. .

Sinus applications would embody:

septoplasty and .
. procedures such as
- . the removal of septal spurs,
- polypectomy, .
- antrostomy, .
- ethmoidectomy/sphenoethmoidectomy, .
- frontal sinus trephination and irrigation, .
- frontal sinus drill out, .
- endoscopic DCR and .
- trans-spehnoidal procedures. .

Nasopharyngeal/Laryngeal procedures would comprise:

adenoidectomy, .
. tracheal,
laryngeal polyectomy, .
laryngeal lesion debulking and .
tonsillectomy. .

Head and neck procedures would encompass:

. soft tissue shaving,
rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), .
removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of . the face, and
. acoustic neuroma removal.

Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.

Prescription Use
(Per 21 CFR 801.109)

Page 3

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K992994

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Page_ of 1 1

K992996

510(k) Number (if known):

Enable Endoscopic Bipolar Scissors Device Name:_

Indications For Use:

The Enable Endoscopic Bipolar Scissors is intended to cut
and and control blooding through coagulation during The Enable Endoscopic Biporal Sersboro culation during
tissue and control bleeding through coagulation during
the control control currical procedures. tissue and control breeding checugical bely

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark n Milkerson

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 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.