transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa
endometrial ablation .

Device Description

The Olympus Resection Electrodes that are subject to this submission are for application in saline. Depending on the characteristics of electrical current, which is provided by the electrosurgical generator, electrosurgery can be used for coagulation, vaporization and cutting.

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

AI/ML Overview

This device is a set of Resection Electrodes for gynecological applications. The submission states that the subject device is identical in design and manufacturing to the predicate device (K152092), and therefore, the current submission relies on performance testing, sterilization, and packaging validation testing previously reviewed and deemed acceptable in K152092.

As such, without access to the K152092 submission, I cannot provide details on the specific acceptance criteria, study design, sample sizes, expert qualifications, or ground truth methods. The provided document for K161600 only states that the performance data for K161600 is based on the performance data of K152092 without re-presenting the actual data for K152092.

However, based solely on the information provided in the K161600 document, I can infer the following about what would have been implicitly accepted given the "identical" claim:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided in K161600 as it defers to K152092. It would typically include metrics related to electrosurgical performance (e.g., cutting efficiency, coagulation effectiveness, impedance characteristics, thermal spread, mechanical stability of the electrodes under stress, durability during use, material biocompatibility, and electrical safety).
Sample sizes used for the test set and data provenance: Not explicitly stated in K161600. These would have been part of the studies for predicate device K152092.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not explicitly stated in K161600. If clinical studies were part of K152092, expert evaluation would have been involved, likely by urologists (for the predicate device's original indication) or potentially other surgeons if generalized tissue effects were assessed.
Adjudication method for the test set: Not explicitly stated in K161600.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This type of study is more common for diagnostic imaging AI devices, not electrosurgical electrodes.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical tool, not an AI algorithm. Its performance is always in conjunction with human use.
The type of ground truth used: Not explicitly stated in K161600. For electrosurgical devices, ground truth might involve objective measurements of tissue effect (e.g., depth of coagulation, width of cut, histological analysis post-ablation), electrical parameters, and mechanical testing results, rather than expert consensus on diagnostic images.
The sample size for the training set: Not applicable. This device is an electrosurgical tool, not an AI/ML algorithm that relies on a training set.
How the ground truth for the training set was established: Not applicable.

However, the document does contain information about the regulatory review and basis for substantial equivalence:

Summary of Acceptance Criteria and Study (Implicitly from K152092):

Since K161600 claims identical design and manufacturing to K152092 and relies on K152092's performance data, the acceptance criteria and study would have been related to demonstrating the safe and effective performance of electrodes for electrosurgical cutting and coagulation.

Key Performance Data Categories (Inferred from industry standards for electrosurgical devices):

Electrical Performance: Power output, impedance matching, current distribution, absence of arcing.
Thermal Performance: Controlled tissue heating, minimal collateral thermal damage, effective coagulation/cutting.
Mechanical Integrity: Durability of the electrode tip, insulation, and shaft during simulated use; resistance to bending and fracturing.
Biocompatibility: Confirmation that materials are biocompatible (typically by testing or established use).
Sterilization Validation: Ensuring the device can be consistently sterilized.
Packaging Validation: Ensuring sterility is maintained until use and transit integrity.

How the Device Meets Acceptance Criteria:

The device meets the acceptance criteria by being identical in design and manufacturing to the previously cleared predicate device K152092, whose performance data was already deemed acceptable by the FDA for urological indications. The K161600 submission argues that despite different indications (gynecological vs. urological), the "intended use" is the same (electrosurgery in saline) and there is an "extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications." This implies that the fundamental performance characteristics demonstrated in K152092 are transferable and acceptable for the new indications.

The document explicitly states:

"The subject device is identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092."
"Sterilization is performed according to ISO 11135 and packaging conforms with ISO 11607-1. Since the subject device is identical in design and manufacturing to the predicate device, the current submission relies on sterilization and packaging validation testing previously reviewed and deemed acceptable in K152092."

Therefore, the "study that proves the device meets the acceptance criteria" is the original set of studies performed for the K152092 submission, which are not detailed in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

Olympus Winter & Ibe GmbH % Dolan Mills Sr. Specialist, Regulatory Affairs Gyrus ACMI, Inc. 136 Turnpike Road Southborough, MA 01772

Re: K161600

Trade/Device Name: Resection Electrodes (model numbers WA47505S, WA47506S. WA47507S, WA47540S, WA47551S, WA47555S, WA47560S, WA47566S) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: JOS, HIH Dated: June 8, 2016 Received: June 9, 2016

Dear Dolan Mills:

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

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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 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/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 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 yours.

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological 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) K161600

Device Name

Resection Electrodes (model numbers WA47505S, WA47507S, WA47507S, WA47551S, WA47551S, WA47550S, WA47566S

Indications for Use (Describe)

Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

transcervical diagnosis and treatment (resection, vaporization, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa
endometrial ablation .

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety and Effectiveness June 8, 2016

1. General Information

Manufacturer:	Olympus Winter & Ibe GmbHKuehnstr. 6122045 HamburgGermanyEstablishment Registration No.: 9610773
Official Correspondent:	Dolan MillsSr. Specialist, Regulatory AffairsGyrus ACMI, Inc.136 Turnpike Rd.Southborough, MA 01772-2104Phone: 901.373.0236Fax: 901.373.0220Email: dolan.mills@olympus-osta.comEstablishment Registration No.: 3003790304

2. Device Identification

Common Name:	Electrode, Electrosurgical / Hysteroscope (and accessories)
Regulation Number:	878.4400 / 884.1690
Classification	Electrosurgical cutting and coagulation device and accessories / Hysteroscope and accessories
Device Class:	II
Product Code:	JOS / HIH
Review Panel:	General & Plastic Surgery / Obstetrics/Gynecology
Proprietary/Trade Name:	Resection Electrodes
Model numbers:	WA47505S, WA47506S, WA47507S, WA47540S, WA47551S, WA47555S, WA47560S, WA47566S

3. Predicate Devices

The subject devices have been previously cleared for urological indications under K152092 (product codes FAS / FJL).

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The predicate devices have not been subject to a design-related recall.

No reference devices were used in this submission.

4. Product Description

The subject HF-Resection Electrodes consist of an active tip, PTFE color code identification, an insulator between the electrode and electrode tube, a guiding tube, telescope clip and arm (shaft).

The design and dimensions of the electrodes vary to accommodate various procedural conditions. The active tips of the various electrodes may consist of loops, rollers, needles or buttons.

All subject Resection Electrodes are single-use electrodes and are delivered sterile and are used in combination with a reusable HF cable (the HF cable is not subject to this submission).

5. Indications for Use

Electrodes are part of a resectoscope system for endoscopic diagnosis and treatment in gynecological applications.

The general indications include transcervical resection, vaporization, ablation, cutting and coagulation of tissue in the uterus in saline irrigation fluid.

Specific indications:

transcervical diagnosis and treatment (resection, vaporization, ablation, biopsy, cutting and coagulation) of intrauterine myomas, intrauterine polyps, synechias and endometrium (TCRis)
lysis of intrauterine septa -
endometrial ablation

Although the subject and predicate devices have different indications for use statements, the intended use is the same. The subject device is indicated for gynecologic applications while the predicate device is indicated for urological indications. However, when the decision-making criteria specified in the FDA

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guidance document, "General/Specific Intended Use," (issued November 4, 1998) are applied, the subject device indications are determined to fall within the scope of the intended use of the predicate device. The specific gynecology indications of the subject device do not represent a different intended use since there is an extensive knowledge base regarding the use of bipolar electrosurgery for gynecological applications, including the disease states listed in the specific gynecologic indications. Therefore, the intended use comparison supports substantial equivalence.

6. Comparison of Technological characteristics

The subject and predicate devices are identical in design and are based on the same technological principle with the same elements:

Identical in design
I Used in combination with a resectoscope system (identical to predicate)
I Like the predicate electrodes, the subject device resection electrode series features loops, needles, rollers, and buttons as active tip shapes
I Utilizing resection in saline as mode of ablation (identical to predicate)

7. Performance Data

The subject device is identical in design and manufacturing to the predicate device (K152092). Therefore, the current submission relies on performance testing previously reviewed and deemed acceptable in K152092.

8. Sterilization and Shelf Life

Sterilization is performed according to ISO 11135 and packaging conforms with ISO 11607-1. Since the subject device is identical in design and manufacturing to the predicate device, the current submission relies on sterilization and packaging validation testing previously reviewed and deemed acceptable in K152092.

9. Conclusion

The subject device is substantially equivalent to the predicate device.

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.