(89 days)
No reference devices were used in this submission.
No
The 510(k) summary describes a standard electrosurgical electrode for use with a resectoscope. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML. The performance testing relies on equivalence to a predicate device, which is common for non-AI/ML devices.
Yes
The device is used for endoscopic diagnosis and treatment of various gynecological conditions, including resection, vaporization, cutting, and coagulation of tissue, which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states "endoscopic diagnosis" and "transcervical diagnosis" as part of the electrode's function.
No
The device description clearly outlines physical components such as an active tip, insulator, guiding tube, telescope clip, and arm (shaft), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The described device is an electrode used as part of a resectoscope system for endoscopic diagnosis and treatment within the uterus. It is used for procedures like cutting, coagulation, and vaporization of tissue inside the body.
- Intended Use: The intended use clearly describes procedures performed directly on tissue within the uterus, not on specimens taken from the body.
Therefore, the function and intended use of this device fall under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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, 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 .
Product codes (comma separated list FDA assigned to the subject device)
JOS, HIH
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines beneath them.
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
1
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 GmbH
Kuehnstr. 61
22045 Hamburg
Germany
Establishment Registration No.: 9610773 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dolan Mills
Sr. Specialist, Regulatory Affairs
Gyrus ACMI, Inc.
136 Turnpike Rd.
Southborough, MA 01772-2104
Phone: 901.373.0236
Fax: 901.373.0220
Email: dolan.mills@olympus-osta.com
Establishment 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 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).
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
5
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.