(133 days)
Not Found
No
The device description focuses on manual operation and mechanical functions (suction, irrigation, puncturing). There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies are bench tests related to mechanical function and reprocessing, not algorithmic performance.
No.
The device is used to assist surgeons in
flushing or removing blood, fluids, and tissue debris from the operation site and is not used for therapeutic purposes.
No
The device's intended use is to provide suction and irrigation during surgical procedures to remove fluids and tissue debris, not to diagnose medical conditions.
No
The device description clearly states it is a system of manually operated, reusable surgical devices consisting of a handle, tubes, cannulae, and needles, which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing suction and/or irrigation during surgical procedures to remove fluids and debris from the operation site. This is a direct intervention on the patient during surgery.
- Device Description: The description details a manually operated surgical device used for puncturing, injecting, and extracting fluids from the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens outside of the body (in vitro) to provide diagnostic information. IVDs are typically used to test samples like blood, urine, or tissue in a laboratory setting to diagnose diseases or conditions.
This device is a surgical instrument used for direct manipulation and management of fluids and tissue within the patient during a procedure, which falls under the category of surgical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, HET
Device Description
The devices in the KARL STORZ Suction and Irrigation System are manually operated, reusable surgical devices consisting of handle, suction/irrigation tubes, cannulae or needles.
The handle is intended to be used in combination with suction/irrigation cannulae and tubing and controls the suction and irrigation. Enabled by the handle with stop cock valve, the regulation of the irrigated quantity of fluids via the tubes, or rather the quantity of aspirated fluid (e.g., blood, fluids, and tissue debris) into or out of the patient is performed.
Cannula and needle: Enabled by the pointed distal end, both puncture and injection/extraction cannulae and needles, perform puncturing of target organs or tissues and injecting fluids into operating site i.e. extracting blood or fluids from them.
The prerequisite for suction is either a vacuum powered suction wall apparatus or a pump, which serve as impulse for the suction. The proximal end of the tube set is connected to the vacuum or pump. Either a pump is required as impulse for irrigation or the natural force of gravity, i.e., by positioning the flush bag at the appropriate height.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.
Indicated Patient Age Range
The KARL STORZ suction and irrigation system is intended to be used for adult population as well as pediatrics (same as Primary and Secondary Predicate Device).
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:
Biocompatibility testing: The system complies with ISO 10993.
Reprocessing Validation Summary: The reprocessing data submitted complies with ANSI/AAMI/ISO 14937:2009, ANSI/AAMI/ISO 11138-3:2017, ANSI/AAMI/ISO 11607-1:2019, ANSI/AAMI/ISO 11737-1:2018, ANSI/AAMI ISO 17664, and ANSI/AAMI/ISO 17665-1:2006/(R)2013.
Bench Top Performance Testing: Additional bench testing was performed to ensure the device met its design specifications and is substantially equivalent to its predicate devices. Tests included Leak Test, Flow Incoming Test, and Flow Outcoming Test.
Clinical Performance 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 primary and secondary predicate device. As such, we concluded that the substantial equivalence of the subject and the primary and secondary predicate devices has been met, and the differences between the subject and both predicate devices do not raise new questions of safety and effectiveness.
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.
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.
0
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, 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.
June 23, 2023
KARL STORZ Endoscopy America, Inc Michael Block Senior Manager, Regulatory Affairs International Submission 2151 E. Grand Avenue El Segundo, California 90245
Re: K230359
Trade/Device Name: KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,1. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-lock (26178P); Injection Needle, dia. 1.2 mm, 36 cm (26175P); Ascites Suction Tube 11 mm (26120S); Suction and Irrigation Tube (26167ANS); Ascites Suction Tube (26175V); Suction and Irrigation Tube (26167ANL); Suction Tube w/ Protection Basket. 36 cm (26173BK); Suction and Irrigation Tube, size 3 mm (26167LHL); Suction and Irrigation Tube, size 3 mm (26167LH); Suction and Irrigation Tube, size 3 mm (26167LHS); Suction and Irrigation Tube, length 30cm (26172BN); Handle with Two-Way Stopcock (30805): Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ, HET Dated: February 10, 2023
Dear Michael Block:
Received: June 15, 2023
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
1
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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling; medical device reporting (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-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 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 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 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.
Image /page/1/Picture/7 description: The image shows the name "Mark Trumbore-S" in large, bold font on the left side. On the right side, it says "Digitally signed by Mark Trumbore-S" and "Date: 2023.06.23 07:51:12-04'00'". This indicates a digital signature by Mark Trumbore on June 23, 2023, at 7:51:12 AM with a -04'00' timezone offset.
Mark Trumbore, Ph.D. Assistant Director, THT4A1: Robotically-Assisted Surgical Devices Team DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula, I. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula.L. 43cm (37460LH): Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-lock (26178P); Injection Needle, dia. 1.2 mm, 36 cm (26175P); Ascites Suction Tube 11 mm (26120S); Suction and Irrigation Tube (26167ANS): Ascites Suction Tube (26175V); Suction and Irrigation Tube (26167ANL); Suction Tube w/ Protection Basket. 36 cm (26173BK): Suction and Irrigation Tube, size 3 mm (26167LHL); Suction and Irrigation Tube, size 3 mm (26167LH); Suction and Irrigation Tube, size 3 mm (26167LHS); Suction and Irrigation Tube, length 30cm (26172BN); Handle with Two-Wav Stopcock (30805): Suction and Irrigation Tube, 43 cm (26174BN); Suction and Irrigation Tube, 36 cm (26173BN); Suction and Irrigation Tube (40360LH)
Indications for Use (Describe)
The KARL STORZ suction and irrigation system (consisting of handle and suction/irrigation tubes, cannulae or needles) is intended for use by qualified surgeons to provide suction and/or irrigation function to help flush or remove blood, fluids, and tissue debris from the operation site during general, gynecologic, urologic, and thoracic laparoscopic surgical procedures.
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 contains 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.
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 Avenue
El Segundo, CA 90245 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Michael Block
Senior Manager, Regulatory Affairs International Submission
KARL STORZ SE & Co. KG
Email: michael.block@karlstorz.com
Phone: +4916093781814 |
| Date of Preparation: | February 10, 2023 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Suction and Irrigation System |
| Common Name: | Suction and Irrigation System |
| Regulatory Class: | II |
| Product Code: | GCJ, HET |
| Classification Name: | 21 CFR 876.1500 Endoscope and accessories
21 CFR 884.1720 Gynecologic laparoscope and accessories |
| Device Panel: | General & Plastic Surgery
Obstetrics/Gynecology |
| Predicate Device(s): | Primary Predicate Device: KARL STORZ Suction/Irrigation Tubes,
Cannulae, Sheaths, cleared via K945059.
Secondary Predicate Device: KARL STORZ Puncture, Injection,
Endoscopic, Veress Needle, cleared via K951190.
These predicate devices have not been subject to a design-related
recall. |
| Device Description: | The devices in the KARL STORZ Suction and Irrigation System are
manually operated, reusable surgical devices consisting of handle,
suction/irrigation tubes, cannulae or needles. |
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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. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.
| | The handle is intended to be used in combination with suction/irrigation
cannulae and tubing and controls the suction and irrigation. Enabled by
the handle with stop cock valve, the regulation of the irrigated quantity
of fluids via the tubes, or rather the quantity of aspirated fluid (e.g.,
blood, fluids, and tissue debris) into or out of the patient is performed.
Cannula and needle: Enabled by the pointed distal end, both puncture
and injection/extraction cannulae and needles, perform puncturing of
target organs or tissues and injecting fluids into operating site i.e.
extracting blood or fluids from them. | | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------|
| | The prerequisite for suction is either a vacuum powered suction wall
apparatus or a pump, which serve as impulse for the suction. The
proximal end of the tube set is connected to the vacuum or pump.
Either a pump is required as impulse for irrigation or the natural force
of gravity, i.e., by positioning the flush bag at the appropriate height. | | | |
| Intended Use: | The KARL STORZ suction and irrigation system (consisting of handle
and suction/irrigation tubes, cannulae or needles) is intended for use by
qualified surgeons to provide suction and/or irrigation function to help
flush or remove blood, fluids, and tissue debris from the operation site
during general, gynecologic, urologic, and thoracic laparoscopic
surgical procedures. | | | |
| Indications For Use: | The KARL STORZ suction and irrigation system (consisting of handle
and suction/irrigation tubes, cannulae or needles) is intended for use by
qualified surgeons to provide suction and/or irrigation function to help
flush or remove blood, fluids, and tissue debris from the operation site
during general, gynecologic, urologic, and thoracic laparoscopic
surgical procedures. | | | |
| Patient Population | The KARL STORZ suction and irrigation system is intended to be used
for adult population as well as pediatrics (same as Primary and
Secondary Predicate Device). | | | |
| Technological
Characteristics: | Comparison Table: Subject vs. Primary and Secondary Predicate
Devices | | | |
| | | Subject Device | Primary
Predicate Device
(K945059) | Secondary
Predicate
Device
(K951190) |
| | Product
Code | GCJ, HET | GCJ | HET |
| | System
Components | Handle and
suction/irrigation | Handle and
suction/irrigation | Injection
needles,
puncture |
| | | tubes, cannulae
or needles | tubes, cannulae
or sheaths | needles,
endoscopic
needles,
biopsy needles
and Veress
needles |
| | Patient
contacting
materials | Surgical grade
stainless steel | Same as subject | Same as
subject |
| | Cleaning | Manual cleaning | Same as subject | Same as
subject |
| | Sterilization
Method(s) | Steam
sterilization | Steam
sterilization or
Ethylene Oxide
Sterilization | Steam
sterilization or
Ethylene
Oxide
Sterilization |
| | Construction | Dismountable | Non-
dismountable | Non-
dismountable |
| | Non-Clinical
Performance Data: | The following non-clinical performance data were provided in support
of the substantial equivalence determination. | | |
| | Biocompatibility testing
The system complies with the following standards:
• ISO 10993 | | | |
| | Reprocessing Validation Summary
The reprocessing data submitted complies with the following standards
with regards to cleaning and sterilization:
• ANSI/AAMI/ISO 14937:2009
• ANSI/AAMI/ISO 11138-3:2017
• ANSI/AAMI/ISO 11607-1:2019
• ANSI/AAMI/ISO 11737-1:2018
• ANSI/AAMI ISO 17664
• ANSI/AAMI/ISO 17665-1:2006/(R)2013 | | | |
| | Bench Top Performance Testing | | | |
| | Additional bench testing was performed to ensure the device met its
design specifications and is substantially equivalent to its predicate
devices.
• Leak Test | | | |
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Image /page/6/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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
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Image /page/7/Picture/0 description: The image shows the logo for STORZ, a company specializing in endoscopes. The logo features the word "STORZ" in large, bold, blue letters. Below the main logo, the words "KARL STORZ - ENDOSKOPE" are written in a smaller, sans-serif font, also in blue.
| Flow Incoming Test Flow Outcoming Test | |
|---|---|
| Clinical | |
| Performance 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 primary and secondary predicate device. As such, we concluded | |
| that the substantial equivalence of the subject and the primary and | |
| secondary predicate devices has been met, and the differences between | |
| the subject and both predicate devices do not raise new questions of | |
| safety and effectiveness. |