(193 days)
The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.
The KARL STORZ Urological Laser Accessories include Sheaths, Obturators, Working Elements, Guiding Probes, Telescope Bridge, Working Insert, and LUER-Lock Tube Connectors and Adaptor.
This FDA 510(k) summary describes Karl Storz Urological Laser Accessories. Based on the provided text, there are no specific AI/ML components mentioned or evaluated through a study. Therefore, the questions related to AI/ML acceptance criteria, performance, and study design are not applicable.
The acceptance criteria and supporting studies focus on traditional medical device performance, biocompatibility, and reprocessing validation.
Here's a breakdown of the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Adherence to Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1, -2, -5, -10, -11, -12, -18, -23 | Device complies with listed ISO 10993 standards, demonstrating biocompatibility. |
| Reprocessing Validation | Compliance with ISO 14937, ISO 17665-1, AAMI TIR 30:2011, ASTM F3208-17, ISO 15883-5 | Reprocessing data submitted complies with the listed standards, ensuring effective cleaning and sterilization. |
| Bench Performance | Device meets design specifications, substantial equivalence to predicate. These are tested through: - System Interlocking Test - Flow Test (comparative) - Bending Force Test | Additional bench testing was performed to ensure the device met its design specifications and is substantially equivalent to its predicate device. Specific quantitative results are not provided in this summary but the conclusion states they were met. |
| Technological Characteristics | The device's technological characteristics (dimensions, components, irrigation method) are compared to the predicate device to confirm substantial equivalence. | Similar system components, continuous flow irrigation/aspiration. - Sheath: Diameter: 23.5-27.6Fr., Length: 216.5-239mm (Predicate: 21-24Fr., 235-260.5mm) - Obturator: Diameter: 19.9-21Fr., Length: 249.5-311.7mm (Predicate: 17.9-21.15Fr., 246.5-377.8mm) - Laser Guide Probe: Length: 342.7-345.7mm (Predicate: N/A) - Working Element: Diameter: 1x 4.4mm, 1x 2.5mm; Length: 2x 4.4mm (Predicate: N/A) - Telescope Bridge: Number of channels: 1 (Predicate: 1-2) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated as this is a non-clinical evaluation. The "sample size" would refer to the number of devices or components tested for biocompatibility, reprocessing, and bench performance. The summary only states that tests were performed.
- Data Provenance: Not applicable in the context of clinical data. For non-clinical testing, it's generally conducted by the manufacturer or accredited labs, and the location is not specified in this summary. The studies are prospective in the sense that they are conducted specifically for regulatory submission, but they are not clinical studies on human subjects.
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 does not involve expert interpretation for ground truth establishment. Its performance is evaluated through objective, non-clinical tests based on established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This device does not involve human readers or interpretation of diagnostic images requiring adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance evaluation was not done. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's evaluation is defined by adherence to recognized international and industry standards for biocompatibility, reprocessing, and engineering design specifications. For example:
- Biocompatibility: ISO 10993 series.
- Reprocessing: ISO 14937, ISO 17665-1, AAMI TIR 30:2011, ASTM F3208-17, ISO 15883-5.
- Bench Performance: Internal design specifications and comparative testing against the predicate.
8. The sample size for the training set
- Not applicable. This device does not involve machine learning and therefore has no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
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September 8, 2023
Karl Storz SE & CO. KG % Emily Rhiel Regulatory Affairs Specialist KARL STORZ Endoscopy-America, Inc. 2151 E. Grand Avenue El Segundo, CA 90245
Re: K230535
Trade/Device Name: KARL STORZ Urological Laser Accessories Regulation Number: 21 CFR§ 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: August 4, 2023 Received: August 7, 2023
Dear Emily Rhiel:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230535
Device Name
KARL STORZ Urological Laser Accessories
Indications for Use (Describe)
The KARL STORZ Urological Laser Accessories are used with laser fibers during urological endoscopic procedures.
The above indications are applicable to the following model numbers:
| 27026 VA |
|---|
| 27026 VI |
| 27026 VIL |
| 27026 OV |
| 27026 VS |
| 27040 SL |
| 27040 SD |
| 27050 SL |
| 27050 SC |
| 27040 ХА |
| 27040 XAL |
| PV27040 XAL-1 |
| 27050 CA |
| 27050 XA |
| 27056 LA |
| 27056 LB |
| 27056 LE |
| 27056 EA |
| 27056 EB |
| 27056 EC |
| 27056 ED |
| 27068 CD |
| 27050 VL |
| 27040 OC |
| 27048 CK |
| 27050 BE |
| 27050 BK |
| 27051 B |
| 27500 |
| 27502 |
| 27026 VY |
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters on the second line.
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 document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
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| Indications for Use: | The KARL STORZ Urological Laser Accessories are used with laser fibersduring urological endoscopic procedures. | ||
|---|---|---|---|
| Model Numbers: | Accessory Type | Model Number | Description |
| Cystoscope Accessories | |||
| Sheaths | 27026 VA | Outer Sheath, 23 Fr. | |
| 27026 VI | Inner Sheath, with 7.5Fr. workingchannel | ||
| 27026 VIL | Inner Sheath | ||
| Obturators | 27026 OV | Obturator, 23 Fr. | |
| 27026 VS | Visual Obturator | ||
| Resectoscope Accessories | |||
| Sheaths | 27040 SL | Resectoscope Sheath, 26 Fr. | |
| 27040 SD | Resectoscope Sheath, 26 Fr. | ||
| 27050 SL | Resectoscope Sheath, 26 Fr. | ||
| 27050 SC | Resectoscope Sheath, 26 Fr. | ||
| 27040 XA | Inner Sheath for 27040 SD/SL | ||
| 27040 XAL | Inner Tube for 27040 SD/SL | ||
| PV27040 XAL-1 | Inner Tube | ||
| 27050 CA | Inner Sheath for 27050 SC | ||
| 27050 XA | Inner Sheath for 27050 SL | ||
| WorkingElements | 27056 LA | Working Element | |
| 27056 LB | |||
| 27056 LE | |||
| Guiding Probes | 27056 EA | LASER Guide Probe, 0.8 mm | |
| 27056 EB | |||
| 27056 EC | |||
| 27056 ED | |||
| Telescope Bridge | 27068 CD | Telescope Bridge | |
| Working Insert | 27050 VL | LASER Working Insert | |
| Obturators | 27040 OC | Standard Obturator | |
| 27048 CK | |||
| 27050 BE | |||
| 27050 BK | |||
| 27051 B | |||
| Compatible Components | |||
| LUER-Lock Tube | 27500 | LUER-Lock Tube Connector | |
| Connectors | 27502 | LUER-Lock Tube Connector | |
| Adaptor | 27026 VY | LASER Cystoscope Adaptor |
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| TechnologicalCharacteristics: | Subject DeviceKARL STORZ UrologicalLaser Accessories | Predicate DeviceKARL STORZ LaserAccessories K942786 | |
|---|---|---|---|
| SystemComponents | Sheath; obturator; workingelement; guide probe;working insert; bridge; laseradaptor; LUER-Lock tubeconnector | Sheath; obturator;cannulae; endoscopes;adaptor; bridge; deflectiondevice; backstop; protector | |
| IrrigationandAspiration | Continuous flow | Same as subject | |
| Sheath | Diameter: 23.5 – 27.6Fr.Length: 216.5 – 239mm | Diameter range: 21 – 24FrLength: 235 – 260.5mm | |
| Obturator | Diameter: 19.9 – 21Fr.Length: 249.5 – 311.7mm | Diameter: 17.9 – 21.15Fr.Length: 246.5 – 377.8mm | |
| Laser GuideProbe | Length: 342.7mm-345.7mm | N/A | |
| WorkingElement | Diameter: 1 x 4.4mm, 1x2.5mmLength: 2x 4.4mm | N/A | |
| TelescopeBridge | Number of channels: 1 | Number of channels: 1 – 2 | |
| Non-ClinicalPerformance Data: | The following non-clinical performance data were provided in support ofthe substantial equivalence determination.Biocompatibility testingThe system complies with the following standards:◦ ISO 10993-1: Biological evaluation of medical devices – Part 1:Evaluation and testing within a risk management process◦ ISO 10993-2: Biological evaluation of medical devices - Part 2:Animal welfare requirements◦ ISO 10993-5: Biological evaluation of medical devices - Part 5:Tests for in vitro cytotoxicity◦ ISO 10993-10: Biological evaluation of medical devices – Part 10:Tests skin sensitization | ||
| ◦ ISO 10993-11: Biological evaluation of medical devices – Part 11:Tests for systemic toxicity◦ ISO 10993-12: Biological evaluation of medical devices - Part 12:Sample preparation and reference materials |
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| ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of materials ISO 10993-23 Biological evaluation of medical devices - Part 23: Tests for irritation 2021 Reprocessing Validation SummaryThe reprocessing data submitted complies with the following standards: ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices AAMI TIR 30:2011: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices. ASTM F3208-17, 2017: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices ISO 15883-5: Washer Disinfectors – Test soils and methods for demonstrating cleaning efficacy Bench Performance TestingAdditional bench testing was performed to ensure the device met its design specifications and is substantially equivalent to its predicate device. System Interlocking Test Flow Test (comparative) Bending Force Test | |
|---|---|
| ClinicalPerformance Data: | Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications. |
| Conclusion: | The conclusions drawn from the non-clinical performance data demonstrated that the subject device is as safe as and as effective as the predicate device. As such, we concluded that the substantial equivalence of the subject and the predicate device has been met, and the differences between the subject and the predicate device do not raise new questions of safety and effectiveness. |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.