(267 days)
Percutaneous System for adults
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.
Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
The Percutaneous Nephroscope System consists of the following:
- Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes
- HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)
- Operating Sheaths
- One-Step Dilators
- Telescope Bougie Set
- Hollow Obturator and Fascial Dilator Applicators
- Biopsy and Grasping forceps
- Scissors
- Knives
- Insertion Aid
- Laser Hand Instrument
- Suction tube
- Adaptors
- Luer-Lock tube connectors
The provided text is a 510(k) summary for the KARL STORZ Percutaneous Nephroscope System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and a literature review for pediatric use.
Based on the provided text, the sections relating to acceptance criteria and the study that proves the device meets them are primarily about non-clinical bench testing and literature review, as opposed to a complex clinical study for AI or image analysis devices.
Here's a breakdown of the information requested, based only on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states: "Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments (forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate."
However, specific numerical acceptance criteria (e.g., minimum tensile strength, maximum insertion force, specific illumination levels) and the precise reported performance values are not explicitly detailed in this 510(k) summary. The summary only generally states that the device "meets all its design specification."
Therefore, a table of specific acceptance criteria and reported performance cannot be fully constructed from the provided text. The document refers to compliance with ISO and IEC standards, which would imply that the device met the performance requirements outlined in those standards.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Compliance with design specifications | "meets all its design specification" |
| Substantial equivalence to predicate device (endoscopes) | Demonstrated through comparative bench testing, the endoscopes in the system are "substantially equivalent to its predicate device." |
| Substantial equivalence to predicate device (instruments) | Demonstrated through additional bench testing for forceps and scissors, ensuring they "met its design specifications and is substantially equivalent to the predicate." |
| Biocompatibility | Met requirements of ISO 10993 series for Cytotoxicity, Acute Systemic Toxicity, Irritation, and Maximization Sensitization. |
| Thermal Safety | Met requirements of IEC 60601-2-18:2009. |
| Reprocessing (Cleaning and Sterilization) | Met requirements of AAMI and ISO standards (TIR12, TIR30, ST77, ST79, ISO 14937, DIN EN ISO 11138-1, ANSI/AAMI/ISO 17655-1) and FDA Guidance on Reprocessing Medical Device in Health Care Settings. |
| Safety and effectiveness for pediatric use (>1 month) | Supported by "Published literature... provided to support the safety and effectiveness of the Percutaneous Nephroscope system for use in pediatrics >1month of age." (Note: This is a clinical performance claim, but the supporting study is a literature review, not a new clinical trial reported within this document.) |
2. Sample size used for the test set and the data provenance
- Sample size: The document does not specify a "sample size" in the context of clinical testing of humans or images. The "test set" refers to the specific devices and instruments undergoing bench testing. The document implies that sufficient units were tested to demonstrate compliance with design specifications and substantial equivalence, but the exact number of devices tested is not stated.
- Data provenance: The document indicates non-clinical bench testing (likely performed internally by the manufacturer or contracted labs) and a literature review. The provenance of the literature is not specified beyond "Published literature." There is no mention of country of origin for any human data (as no new human clinical studies were performed). The testing is implicitly prospective in the sense that the manufacturer conducted the tests for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the data provided. The "ground truth" for this type of device submission (Percutaneous Nephroscope System) is established through engineering and performance specifications validated by bench testing and adherence to recognized standards. There isn't a "test set" of patient images or clinical cases requiring expert interpretation to establish ground truth in the way it would be for an AI diagnostic device. The "ground truth" for the pediatric indication was established through existing published literature, not by new expert consensus specifically for this submission.
4. Adjudication method for the test set
This information is not applicable as there are no human-read test sets requiring adjudication of interpretations. The tests are bench tests proving physical and functional characteristics.
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
No, an MRMC comparative effectiveness study was not done, and this type of study is not relevant to a Percutaneous Nephroscope System. This device is a surgical instrument, not an AI-assisted diagnostic or image analysis tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" is based on engineering design specifications, established performance standards (ISO, IEC, AAMI), and the performance of the predicate device. For the pediatric indication, the "ground truth" for safety and effectiveness was established from published literature, which likely includes clinical outcomes data, expert opinions, and various study types from prior research involving similar devices/procedures in pediatrics.
8. The sample size for the training set
This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" in the context of an AI/machine learning model for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 1, 2024
Karl Storz SE & Co. Kg Alita McElroy Senior Specialist, Regulatory Affairs Dr.-Karl-Storz-Straße 34 Baden-Wurttemberg Tuttlingen, 78532 GERMANY
Re: K232370
Trade/Device Name: Percutaneous Nephroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGA Received: March 29, 2024
Dear Alita McElroy:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
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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,
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Percutaneous Nephroscope System
Indications for Use (Describe)
Percutaneous System for adults The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults.
Percutaneous System for adults and pediatrics
The KARL STORZ Percutaneous System is intended to be used during percutaneous removal of kidney stones in adults and pediatrics >1month of age.
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.
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
K232370 Page 1 of 5
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
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. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEl Segundo, CA 90245 |
|---|---|
| Contact: | Alita McElroySenior Regulatory Affairs SpecialistPhone: (424) 218-8376Email: Alita.McElroy@karlstorz.com |
| Date ofPreparation: | August 7, 2023 |
| Type of 510(k)Submission: | Traditional |
| DeviceIdentification: | Trade Name: Percutaneous Nephroscope SystemClassification Name: Kit, Nephroscope (21 CFR 876.1500) |
| Regulatory Class: | II |
| Product Code: | FGA |
| ClassificationPanel: | Gastroenterology/Urology |
| PredicateDevice(s): | KARL STORZ Adult and Pediatric Nephroscope (K940594) |
| DeviceDescription: | The Percutaneous Nephroscope System consists of the following:- Minimally Invasive Percutaneous Nephrolithopaxy (MIP) Nephroscopes- HOPKINS Telescopes for Percutaneous Nephrolithotomy (PCNL)- Operating Sheaths- One-Step Dilators- Telescope Bougie Set- Hollow Obturator and Fascial Dilator Applicators- Biopsy and Grasping forceps- Scissors- Knives |
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Image /page/5/Picture/0 description: The image shows the logo for STORZ. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is simple and professional.
| - | Insertion Aid | ||
|---|---|---|---|
| - | Laser Hand Instrument | ||
| - | Suction tube | ||
| - | Adaptors | ||
| - | Luer-Lock tube connectors | ||
| Intended Use andIndications forUse: | The dilators are used to dilate the access tract to the punctured kidney. Theoperating sheath is inserted in the pre-expanded tract and facilitates insertionof the MIP Nephroscopes or the HOPKINS Telescopes for PCNL. The desiredinstrument (e.g forceps, scissors, knives) for stone removal is introducedthrough the working channel of the HOPKINS Telescopes or into the MIPNephroscopes via an instrument port. A suction tube can alternatively be usedvia the working channel of the MIP Nephroscopes to suction stone fragments.The laser hand instrument or an insertion aid is used to guide a laser fiber forstone fragmentation. Applicators are used to seal the access tract of the kidney.Percutaneous System for adultsThe KARL STORZ Percutaneous System is intended to be used duringpercutaneous removal of kidney stones in adults.Percutaneous System for adults and pediatricsThe KARL STORZ Percutaneous System is intended to be used duringpercutaneous removal of kidney stones in adults and pediatrics >1month ofage. | ||
| TechnologicalCharacteristics. | PercutaneousNephroscope SystemSubject Device | KARL STORZ Adult andPediatric NephroscopeSystemPredicate DeviceK940594 | |
| Components | MIP NephroscopesHOPKINS TelescopesOperating SheathsHollow ObturatorFascial DilatorTelescope Bougie SetOne-Step DilatorsGrasping ForcepsBiopsy ForcepsKnivesScissors | Nephroscopes withinstrument channelTelescopes withoutinstrument channel andluer-lock connector tubesOperating SheathsDilation SetHollow Obturator FascialDilatorGrasping ForcepsBiopsy Forceps |
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K232370 Page 3 of 5
Image /page/6/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
| Applicator | Knives | ||
|---|---|---|---|
| Insertion Aid | Scissors | ||
| Laser Hand Instrument | Triradiate Graspers | ||
| Suction tube | Kidney Stone crushers | ||
| Adaptors | |||
| Luer-lock connectortubes | |||
| Scope Type | Rigid, rod lens andfiber-optic | Rigid, rod lens | |
| Scope OuterDiameter | 3.3mm- 7.5mm | 2.7mm- 6mm, 5 x 3mm | |
| ScopeWorkingLength | 20cm- 26cm | 10cm -30cm | |
| Instrumentchannelwidth | 0.8- 5mm | 2.5mm- 4.7mm | |
| ScopeDirection ofView | 6°, 7.5°, 10° | 0° | |
| Scope Fieldof View | 72°- 102° | 65°- 118° | |
| Depth ofField | 4mm- 200mm | 4mm- 200mm | |
| 5.5mm- 200mm | 5.1mm- 200mm | ||
| 6.6mm- 200mm | |||
| 7.6mm- 200mm | |||
| 8.0mm- 200mm | |||
| Irrigationand Suction | Continuous Flow | Continuous Flow | |
| Vacuum-Cleanereffect | Yes | No | |
| OperatingSheathdimensions | Diameter: 11/12 Fr- 26FrWorking Length:7.5cm- 22.8cm | Diameter: 17 Fr- 33 FrWorking Length: 10cm-20cm | |
| Telescope | Dilation Cannula | Dilation/Puncture Cannula | |
| Bougie/Dilation Set | Diameter: 3.8mm | Diameter: 4mm | |
| dimensions | Working length: 12.6cm | Working Length: 15cm | |
| Guide wirediameter: 1.9mm, ballend: 3mmworking length: 57cm | Guide wirediameter: 1.9mm, ball end:2.9mmworking length: 57.5cm | ||
| DilatorsDiameter: 9, 12, 15, 18,21, 24, 27, 30FrWorking Length: 27-29cm | DilatorsDiameter: 9, 12, 15, 18, 21,24, 27, 30FrWorking Length: 10-18cm | ||
| HollowObturatorand FascialDilatordimensions | Diameter: 6.7mm- 8mmWorking Length:20.8cm - 27cm | Diameter: 5mm- 7mmWorking Length: 10cm-15cm | |
| BiopsyForcepsdimensions | Diameter: 1.67mm -3.5mmWorking Length:39cm - 40cm | Diameter: 1.67- 3.5mmWorking Length: 12cm-31cm | |
| GraspingForcepsdimensions | Diameter: 1.67mm -3.5mmWorking Length:40cm | Diameter: 1.67mm- 3.5mmWorking Length: 12cm-31cm | |
| Scissorsdimensions | Diameter: 1.7mm -3.5mmWorking Length:40cm | Diameter: not included in510kWorking Length: 31cm | |
| Knivesdimensions | Diameter: 3.5mmWorking Length:38cm | Diameter: not included in510kWorking Length: 31cm | |
| 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 Percutaneous Nephroscope System is tested in accordance with the following standards and FDA Guidance: |
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Image /page/7/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
K232370
Page 4 of 5
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
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K232370 Page 5 of 5
Image /page/8/Picture/1 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.
KARL STORZ Premarket Notification Percutaneous Nephroscope System 510(k) Summary
SO Endoscopic Standards
- ISO 8600-1
- ISO 8600-3
- ISO 8600-5
- ISO 8600-6
Biocompatibility Summary
- Cytotoxicity (ISO 10993-5:2009) ●
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
- Irritation (ISO 10993-23:2021)
- Maximization Sensitization (ISO 10993-10:2021) ●
Thermal Safety
- IEC 60601-2-18:2009 (3RD Edition) ●
Reprocessing (Cleaning and Sterilization)
- AAMI TIR12: 2010 ●
- AAMI TIR30: 2011 ●
- ANSI/AAMI ST77:2013/(R)2018 ●
- ANSI/AAMI ST79:2017 ●
- AAMI/ISO 14937:2009
- DIN EN ISO 11138-1:2017
- ANSI/AAMI/ISO 17655-1:2006/(R)2013 ●
- Reprocessing Medical Device in Health Care Settings: Validation ● Methods and Labeling
Comparative bench testing between the subject and predicate DEVICES demonstrated that the endoscopes in the Percutaneous Nephroscope System meets all its design specification and is substantially equivalent to its predicate device. Additional bench testing was performed for the subject device instruments
(forceps and scissors) to ensure the device met its design specifications and is substantially equivalent to the predicate.
| Clinical | Published literature was provided to support the safety and effectiveness of |
|---|---|
| Performance Data: | the Percutaneous Nephroscope system for use in pediatrics >1month of age. |
The conclusions drawn from the nonclinical test demonstrate that the Conclusion: subject device is as safe and effective as the predicate device.
§ 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.