(261 days)
No
The 510(k) summary describes a standard electrosurgical resectoscope and does not mention any AI or ML capabilities, image processing, or data training/testing.
Yes
Explanation: The device is used for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic procedures, which are considered therapeutic interventions.
No
The device is primarily intended for therapeutic procedures (cutting, ablation, vaporization, and coagulation of tissue). While the "Device Description" mentions "examination, diagnosis and/or therapy," the overwhelming focus of the "Intended Use / Indications for Use" and the functionalities described are therapeutic.
No
The device description explicitly states it consists of physical components like a sheath, obturator, working element, and HF electrode, which are hardware. The performance studies also focus on hardware testing (electrical safety, mechanical forces, etc.).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Intended Use: The intended use of the KARL STORZ bipolar resectoscopes is for cutting, ablation, vaporization, and/or coagulation of tissue during endoscopic procedures. This is a therapeutic and surgical function performed directly on the patient's tissue, not an examination of a specimen outside the body.
- Device Description: The description clearly states it's used for "endoscopically controlled ablation of tissue" and is a combination of a scope and electrosurgical instruments. This aligns with a surgical device, not a diagnostic one that analyzes samples.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens. The device acts directly on the tissue within the body.
Therefore, the KARL STORZ bipolar resectoscopes with HF cable are surgical devices used for therapeutic procedures, not IVDs.
N/A
Intended Use / Indications for Use
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures.
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures
Indications for Use in UROLOGY and GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
FJL, FAS, HIH, FDC
Device Description
Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology) or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator, working element and HF electrode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urological, hysteroscopic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons
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)
Non-Clinical Performance Data: There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC IEC 60601-1; IEC 60601-1-2; IEC 60601-2-18; ISO 10993. Performance Testing: Attachment/Detachment force of the electrode; System Interlocking Test; Flow Test (comparative); Bending Force Test; HF Tissue and HF Durability Test. Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the KARL STORZ Bipolar Resectoscope has met all its design specification and is substantially equivalent to the predicate device.
Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
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.
K882270, K061541, K122983, K171717
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
§ 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.
0
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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
March 17, 2023
KARL STORZ Endoscopy America, Inc Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K221893 Trade/Device Name: KARL STORZ Bipolar Resectoscopes with HF Cable Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FJL, FAS, HIH, FDC Dated: June 28, 2022 Received: February 13, 2023
Dear Mario Trujillo:
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. 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/cfpmn/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
1
Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221893
Device Name
KARL STORZ Bipolar Resectoscopes with HF cable
Indications for Use (Describe)
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The following models are intended for the aforementioned use: 27040AO, 27040BK, 27040BC, 27040BP, 27040SD, 27040SL, 27040SM, 27040XB, 27050CA, 27050CB, 27050SC, 27050SD, 27050SL, 27050SM, 27050XA, 27050XB, 27051XA, 27054CB, 27054CB, 27054SC, 27054XB, 27241AO, 27241BK, 27241BO, 27040BB, 27040OA, 27040OB, 27040OC, 27040OD, 27048BK, 27048CO, 27050AE, 27050AK, 27050BE, 27050BK, 27051B, 27054CO, PV27051B, 27040DB, 27040EO, 27040EB, 27040BL1 - S, 27040BLO1 - S, 27040GD1 - S, 27040GP1 - S, 27040GP140 - S, 27040GP140 - S, 27040GPO1 - S, 27040JB1 - S, 27040JB1 - S, 27040JB130-S,27040JBE130-S,27040NB-S,27040NBO-S,27040VE-S.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K221893
Device Name
KARL STORZ Bipolar Resectoscopes with HF Cable
Indications for Use (Describe)
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic electrosurgical procedures.
The following models are intended for the aforementioned use: 26040XA, 26050CA, 26050SL, 26050XA, 26053CB, 26053SC, 26055CB, 26055LD, 26055SC, 26055XB, 26055XE, 26053OC, 26055CO, 260400C, 26053EB, 26040EB, 26055EB, 26040BL1-S, 26040JB1-S, 26040NB-S, 26055BL1 - S, 26055GP1 - S. 26055NB- S.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K221893
Device Name
KARL STORZ Bipolar Resectoscopes with HF Cable
Indications for Use (Describe)
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
The following models are intended for the aforementioned use: 011050-10, 011052-10, 011160-10, 011163-10, UH801.
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this docurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email: Mario.Trujillo@karlstorz.com |
| Date of
Preparation: | June 23, 2022 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ Bipolar Resectoscopes with HF cable
Common Name: Resectoscope (Product code FJL)
Classification Name: Endoscope and Accessories (21 CFR Part 876.1500); |
| Regulatory
Class: | 2 |
| Product Code: | FJL (FAS, HIH, FDC) |
| Guidance
Document: | Not Applicable |
| Predicate
Devices: | Resection Electrodes with HF cable (K210651) |
| Reference
Devices: | KARL STORZ 27040 & 27050 Continuous Flow Resectoscopes (K882270)
KSEA Bipolar Electrotome (K061541)
KSEA Bipolar Electrode (K122983)
KARL STORZ AUTOCON III 400 (K171717) |
| Device
Description: | Resectoscopes are used for endoscopically controlled ablation of tissue. They are used for
examination, diagnosis and/or therapy in conjunction with endoscopic accessories in medical
disciplines such as Urology and Gynecology. A resectoscope is a combined cystoscope (urology)
or hysteroscope (gynecology) and electrosurgical instruments and consists of a sheath, obturator,
working element and HF electrode. |
6
Image /page/6/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Indications For Use: | Indications for Use in UROLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological procedures.
The following models are intended for the aforementioned use: 27040AK, 27040AO, 27040BK, 27040BO, 27040BP, 27040SD, 27040SL, 27040SM, 27040XA, 27040XB, 27050CA, 27050CB, 27050SC, 27050SD, 27050SL, 27050SM, 27050XA, 27050XB, 27051PL, 27051XA, 27054CB, 27054SC, 27054SL, 27054XB, 27241AO, 27241BK, 27241BO, 27040BB, 27040OA, 27040OB, 27040OC, 27040OD, 27048BK, 27048CK, 27048CO, 27050AE, 27050AK, 27050BE, 27050BK, 27051A, 27051B, 27054CO, PV27051B, 27040DB, 27040EO, 27040BL1 – S, 27040BLO1 – S, 27040GD1 – S, 27040GP1 – S, 27040GP130 – S, 27040GP140 – S, 27040GPB1 – S, 27040GPO1 – S, 27040JB1 – S, 27040JB130 – S, 27040JBE130 - S, 27040NB – S, 27040NBO – S, 27040VE – S. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use in GYNECOLOGY: The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic hysteroscopic electrosurgical procedures
The following models are intended for the aforementioned use: 26040SL, 26040XA, 26050CA, 26050SC, 26050SL, 26050XA, 26053CB, 26053SC, 26055CB, 26055LD, 26055SC, 26055SL, 26055XB, 26055XE, 26053OC, 26055CO, 26040OC, 26053EB, 26040EB, 26055EB, 26040BL1-S, 26040GP1-S, 26040JB1-S, 26040NB-S, 26055BL1 - S, 26055GP1 - S, 26055NB- S. |
| | Indications for Use in UROLOGY and GYNECOLOGY
The KARL STORZ bipolar resectoscopes with HF cable are intended for use by qualified surgeons for cutting, ablation, vaporization, and/or coagulation of tissue during various endoscopic urological and hysteroscopic electrosurgical procedures.
The following models are intended for the aforementioned use: 011050-10, 011051-10, 011052-10, 011160-10, 011163-10, UH801. |
7
Image /page/7/Picture/0 description: The image is a logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in a smaller font.
KARL STORZ Premarket Notification KARL STORZ Bipolar Resectoscopes with HF cable(K221893) 510(k) Summary
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate Devices | ||
|---|---|---|---|
| Subject device | |||
| K221893 | Predicate Device | ||
| K210651 | |||
| Mode of ablation | Bipolar | Same as subject | |
| Irrigation solution | Saline | Same as Subject | |
| Working Length (mm) | 184,7 - 270 | 261.8 - 336.7 | |
| Compatible scope shaft | |||
| diameter (FR) | 15 – 28 | 24 | |
| Electrode Active tip shapes | Loop, needle, roller, button | Loop, band, needle, roller, button | |
| Electrode Active tip designs | 55° - 135° | 12° - 30° angles | |
| Stabilizing tube diameter | |||
| (mm) | 4.95 – 9.6 mm | 4.1 | |
| HF Cables packaged with | |||
| device | Yes | Same as subject | |
| Shelf life | 3 years | Same as subject | |
| Non-Clinical | |||
| Performance | |||
| Data: | There are no performance standards or special controls developed under Section 514 of the | ||
| FD&C Act for endoscopes. However, the subject device follows the FDA recognized consensus | |||
| standards and is tested according to the following standards and FDA Guidance: | |||
| Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 ISO 10993 Performance Testing Attachment/Detachment force of the electrode System Interlocking Test Flow Test (comparative) Bending Force Test HF Tissue and HF Durability Test | |||
| Additional bench testing was performed to ensure the device met its design specifications. The | |||
| bench testing performed verified and validated that the KARL STORZ Bipolar Resectoscope has | |||
| met all its design specification and is substantially equivalent to the predicate device. | |||
| Clinical | |||
| Performance | |||
| Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate | ||
| device. Non-clinical bench testing was sufficient to establish the substantial equivalence of the | |||
| modifications. | |||
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject device, the KARL | ||
| STORZ Bipolar Resectoscope, performs as well as or better than devices that are currently | |||
| marketed for the same intended use. |