(96 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device acts as a port of entry for other instruments and does not itself treat or provide therapy.
No
This device, a trocar, is used to create and maintain a port of entry for instruments during surgical procedures. Its function is to provide access, not to diagnose a condition.
No
The device description clearly outlines physical components (cannula, trocar, valve seal) and mentions bench testing related to mechanical properties and biocompatibility, indicating it is a hardware device. The statement "The subject device does not require... software validation documentation" further confirms it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the trocars are used "during endoscopic and laparoscopic procedures... to create and maintain a port of entry." This describes a surgical instrument used in vivo (within the body) to facilitate access for other instruments.
- Device Description: The description details the physical components of the trocar (cannula, trocar, valve seal) and their function in creating and maintaining a port. This aligns with a surgical access device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, tissue, or other bodily fluids, for diagnostic purposes. The device does not perform tests or provide diagnostic information based on biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and procedural, not diagnostic.
N/A
Intended Use / Indications for Use
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The KARL STORZ New Generation Trocars provide a port of entry during endoscopic and laparoscopic procedures in pediatric and adult patients. The New Generation Trocars are available in diameters 2.5mm to 13.5mm and consist of a cannula, trocar, and a valve seal. The trocars combine single-use and reusable components since the valve seal is single use while the cannula and trocar are reusable components. The trocars are color coded by size and are available with pyramidal, conical, or conical-blunt tips. Reducers can be used to reduce the size of the trocar to accommodate a smaller instrument without losing pneumoperitoneum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
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)
Bench verification performance testing has been performed for the following parameters:
• Seal Leak Test
• Seal Leak Test while Under Torque
• Instrument Insertion and Retention Test
• Penetration Force
• Compression Testing of the Cannula
• Bending Testing of the Cannula
• Torsional Testing of the Cannula
Biocompatibility evaluation was performed to:
• ISO 10993
Sterility of the Reusable Components was validated in accordance with:
• ISO 11135
Sterility of the Sterile Single Use Components was validated in accordance with:
• ISO 11135
• ISO 10993
• ISO 11737
Packaging for the Sterile Single Use Components was validated to: ISO 11607
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.
KARL STORZ Trocars (K940347)
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.
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".
July 18, 2018
KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin Regulatory Engineer 2151 E. Grand Avenue El Segundo, California 90245
Re: K180977
Trade/Device Name: KARL STORZ New Generation Trocars Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: June 8, 2018 Received: June 11, 2018
Dear AnnaLisa Smullin:
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, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K180977
Device Name KARL STORZ New Generation Trocars
Indications for Use (Describe)
KARL STORZ New Generation Trocars are intended to be used during endoscopic and laparoscopic procedures in general surgery and thoracoscopy in adult and pediatric patients to create and maintain a port of entry.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows 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 K180977
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 Avenue
EI Segundo, CA 90245 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | AnnaLisa Smullin
Regulatory Engineer
Phone: (424) 218-8376
Fax: (424) 218-8519 |
| Date of
Preparation: | July 9, 2018 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ New Generation Trocars
Classification Name: Laparoscope, General & Plastic Surgery |
| Regulatory
Class: | II |
| Product Code: | GCJ |
| Regulation: | 21 CFR 876.1500 |
| Predicate
Device: | Primary Predicate Device: KARL STORZ Trocars (K940347)
The predicate device has not been subject to a design-related recall. |
| Device
Description: | The KARL STORZ New Generation Trocars provide a port of entry during
endoscopic and laparoscopic procedures in pediatric and adult patients. The
New Generation Trocars are available in diameters 2.5mm to 13.5mm and
consist of a cannula, trocar, and a valve seal. The trocars combine single-
use and reusable components since the valve seal is single use while the
cannula and trocar are reusable components. The trocars are color coded by
size and are available with pyramidal, conical, or conical-blunt tips.
Reducers can be used to reduce the size of the trocar to accommodate a
smaller instrument without losing pneumoperitoneum. |
| Intended Use: | To create and maintain a port of entry. |
| Indications For
Use: | KARL STORZ New Generation Trocars are intended to be used during
endoscopic and laparoscopic procedures in general surgery and
thoracoscopy in adult and pediatric patients to create and maintain a port of
entry. |
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Image /page/4/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.
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate Device | ||
|---|---|---|---|
| Subject Device | Predicate Device, K940347 | ||
| KARL STORZ New | |||
| Generation Trocars | KARL STORZ Trocars | ||
| Indication for Use | Indication for Use | ||
| Indications for Use | Intended to be used during | ||
| endoscopic and laparoscopic | |||
| procedures in general surgery | |||
| and thoracoscopy in adult and | |||
| pediatric patients to create andmaintain a port of entry. | Intended to be used during | ||
| endoscopic and laparoscopic | |||
| procedures in general surgery | |||
| and thoracoscopy to create | |||
| and maintain a port of entry. | |||
| Product Code | GCJ | GCJ | |
| Target Population | Adult and pediatric general | ||
| population | Adult and pediatric general | ||
| population | |||
| Physical Characteristics | |||
| Diameter | 2.5-13.5 mm | 3.3-15 mm | |
| Length | 5 or 10 cm | 5-16 cm | |
| Tip Design | Pyramidal, conical, blunt | Pyramidal, conical, blunt | |
| Method of Action | Manual Insertion | Manual Insertion | |
| Trocar Material | Stainless Steel | Stainless Steel | |
| Cannula Material | Stainless Steel | Stainless Steel | |
| Trocar Housing | |||
| Material | PEEK (Polyether Ether | ||
| Ketone) | Stainless Steel | ||
| Cleaning and Sterilization Methods | |||
| Reusable Components | Trocar, Cannula, Reducer | Trocar, Cannula, Valve, | |
| Reducer | |||
| Cleaning | Manual | Manual | |
| Sterilization | Steam | Steam, EtO | |
| Sterile Single-Use | |||
| Components | Valve Seals | None | |
| Non-Clinical | |||
| Performance | |||
| Data: | Bench verification performance testing has been performed for the | ||
| following parameters: | |||
| • Seal Leak Test | |||
| • Seal Leak Test while Under Torque | |||
| • Instrument Insertion and Retention Test | |||
| • Penetration Force | |||
| • Compression Testing of the Cannula | |||
| • Bending Testing of the Cannula | |||
| • Torsional Testing of the Cannula | |||
| Biocompatibility evaluation was performed to: | |||
| • ISO 10993 | |||
| Sterility of the Reusable Components was validated in accordance with: | |||
| • ISO 11135 | |||
| Sterility of the Sterile Single Use Components was validated in accordance | |||
| with: | |||
| • ISO 11135 | |||
| • ISO 10993 |
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Image /page/5/Picture/0 description: The image shows 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, blue letters on the bottom line.
| | ISO 11737
Packaging for the Sterile Single Use Components was validated to: ISO 11607 The subject device does not require electromagnetic compatibility, electrical
safety, or software validation documentation. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical
Performance
Data: | Clinical testing was not required to demonstrate substantial equivalence to
the predicate device. Non-clinical bench testing was sufficient to assess
safety and effectiveness and to establish the substantial equivalence. |
| Medical
Literature: | The following real world evidence (literature) was used to support the use
of the KARL STORZ New Generation Trocars in a pediatric population as
well as to demonstrate the safety and effectiveness of the subject device and
its substantial equivalence to the predicate: Blinman, T. & Ponsky, T. Pediatric Minimally Invasive Surgery:
Laparoscopy and Thoracoscopy in Infants and Children. Pediatrics 130,
539-549 (2012). Mitul, A. R. & Sarin, Y. K. Minimal Access Surgery in Neonates. J.
Neonatal Surg. 6, (2017). Slater, B. J. & Rothenberg, S. S. Minimally Invasive Approaches to
GERD and Hiatal Hernia in Children. The SAGES Manual of Pediatric
Minimally Invasive Surgery 315-326 (Springer, Cham, 2017). Bruns, N. E. & DeRoss, A. L. Laparoscopic Management of
Intussusception. In The SAGES Manual of Pediatric Minimally
Invasive Surgery 443–450 (Springer, Cham, 2017). Wei, J. & Feng, J. Laparoscopic treatment of liver diseases in children.
Front. Med. 5, 388-394 (2011). Ishimaru, T. & Iwanaka, T. Laparoscopy and Thoracoscopy. Operative
Gen Surgery in Neonates and Infants 21–29 (Springer, Tokyo, 2016). Hanna, G. B. & Cuschieri, A. Ergonomics of Task Performance in
Endoscopic Surgery. 12 Kurtz, Steven M., and John N. Devine. "PEEK Biomaterials in
Trauma, Orthopedic, and Spinal Implants.” Biomaterials, vol. 28, no.
32, 2007, pp. 4845-4869. Wei, Jia, and Jiexiong Feng. “Laparoscopic Treatment of Liver
Diseases in Children." Frontiers of Medicine, vol. 5, no. 4, 2011, pp.
388-394. Bharathi, Ramanathan Saranga, et al. “Minimal Access Surgery of
Pediatric Inguinal Hernias: a Review." Surgical Endoscopy, vol. 22,
no. 8, 2008, pp. 1751–1762. Mattei, Peter. "Minimally Invasive Surgery in the Diagnosis and
Treatment of Abdominal Pain in Children." Current Opinion in
Pediatrics, vol. 19, no. 3, 2007, pp. 338-343. |
| Conclusion: | The conclusions drawn from the non-clinical tests demonstrate that the
subject device, KARL STORZ New Generation Trocars, performs as well
as or better than the legally marketed predicate device. |