(170 days)
Not Found
No
The device description and intended use describe a purely mechanical surgical instrument (trocar) with no mention of software, data processing, or any AI/ML related terms. The performance studies rely on equivalence to a predicate device, not on algorithmic performance.
No
A therapeutic device is one that treats a disease or condition. This device, a surgical trocar, is used to provide a port of entry for surgical instruments during laparoscopic procedures, serving as an access tool rather than directly performing a therapeutic function.
No
Explanation: The device, a surgical trocar, is used to provide a port of entry for laparoscopic instruments during surgical procedures. Its function is to facilitate instrument access, not to diagnose a condition or disease.
No
The device description clearly details physical components made of plastic and stainless steel, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a port of entry for laparoscopic instruments" during surgical procedures. This is a surgical tool used in vivo (within the body), not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a physical surgical instrument (trocar) used for creating access points. It does not describe any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting.
The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas.
The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.
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
Not Found
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)
The subject device trocar models (Bladeless Trocar, Hasson Trocar) are manufactured by the same company that manufactures those of the predicate device (Unimicro) and are identical to those cleared under K141594. As such, performance testing is not required.
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.
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October 4, 2024
Advamedix, GmbH % Marianne Jacklyn President and Principal Consultant TRAXN Consulting LLC 1235 Swift Shore Circle West Linn, Oregon 97068
Re: K241052
Trade/Device Name: Bladeless Trocar; Bladed Trocar; Hasson Trocar Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: September 5, 2024 Received: September 6, 2024
Dear Marianne Jacklyn:
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/cdrb/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.
1
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" (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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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-regulatory
2
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,
Long H. Chen -> Digitally signed by Long H.Chen -S
Digitally signed Date: 2024.10.04 17:26:30 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
or Use
Submission Number (if known)
K241052
Device Name
Bladeless Trocar;
Bladed Trocar;
Hasson Trocar
Indications for Use (Describe)
The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.
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)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92
1 Contact Details: 21 CFR 807.92(a)(1)
| Applicant Name | Advamedix, GmbH |
|---|---|
| Applicant Address | Greschbachstr 3/3, OG Karlsruhe 76229 |
| Germany | |
| Applicant Contact Telephone | Phone: +49 721 94552 |
| Applicant Contact | Dr. Islam Abed, Director |
| Applicant Contact Email | abed@advamedix.net |
| Correspondent Name | TRAXN Consulting LLC |
| Correspondent Address | 1235 Swift Shore Circle, West Linn, Oregon 97068 |
| United States | |
| Correspondent Contact Telephone | (503) 729-9633 |
| Correspondent Contact | Ms. Marianne D. Jacklyn |
| Correspondent Contact Email | mjacklyn@traxnconsulting.com |
2 Device Name: 21 CFR 807.92(a)(2)
| Trade Name | Bladeless Trocar, Bladed Trocar, Hasson Trocar |
|---|---|
| Common Name | Trocar |
| Classification Name | Endoscope and Accessories |
| Regulation Number | 876.1500 |
| Product Code(s) | GCJ |
Legally Marketed Predicate Devices: 21 CFR 807.92(a)(3) ന
K141594, Unimicro Trocar Kit, models: Auto-Locking Trocar, Hasson Trocar, Bladeless Trocar
Device Description Summary: 21 CFR 807.92(a)(4) 4
The Disposable Surgical Trocar is composed of two parts, one obturator and one guide tube (cannula). The obturator of the Bladeless Trocar is plastic allowing the surgeon to dilate between tissues. The obturator of Bladed Trocar is made of PC and a small blade made of stainless steel, which is released when the surgeon presses the trocar to help with cutting.
5
The Disposable Surgical Trocar Kit, bladed or bladeless, has one obturator and two cannulas or two obturators and four cannulas.
The device is for single use only. This device is sterilized with ethylene oxide and has a shelf life of 3 years.
Intended Use/Indications for Use: 21 CFR 807.92(a)(5) 5
The Bladeless Trocar, Bladed Trocar, and Hasson Trocar have application in a variety of laparoscopic procedures to provide a port of entry for laparoscopic instruments.
6 Indications for Use Comparison: 21 CFR 807.92(a)(5)
The indications for use are the same for the proposed devices and the predicate devices.
| Device & Predicate
| Device(s) | K241052 | K141594 |
|---|---|---|
| Principles of | ||
| Operation | During the operation, the trocar sleeve | |
| and the obturator are used together. | ||
| The surgeon uses the obturator to | ||
| expand the incision of the abdomen | ||
| and penetrates the trocar sleeve | ||
| through the abdominal surface of the | ||
| human body into the abdominal cavity, | ||
| thereby delivering gas to the abdominal | ||
| cavity and establishing a path of entry | ||
| for surgical instruments. | During the operation, the trocar sleeve | |
| and the obturator are used together. | ||
| The surgeon uses the obturator to | ||
| expand the incision of the abdomen | ||
| and penetrates the trocar sleeve | ||
| through the abdominal surface of the | ||
| human body into the abdominal cavity, | ||
| thereby delivering gas to the abdominal | ||
| cavity and establishing a path of entry | ||
| for surgical instruments. | ||
| Main Components | obturator, cannula | obturator, cannula |
| Models | Bladeless | |
| Bladed | ||
| Hasson | Bladeless | |
| Bladed | ||
| Hasson | ||
| Dimensions | ||
| (Overall) | Diameter: 5-12 mm | |
| Length: 100 mm | Diameter: 5-12 mm | |
| Length: 70 - 120 mm |
7 Technological Comparison: 21 CFR 807.92(a)(6)
Non-clinical and/or Clinical Tests Summary & Conclusions: 21 CFR 807.92(b) 8
The subject device trocar models (Bladeless Trocar, Hasson Trocar) are manufactured by the same company that manufactures those of the predicate device (Unimicro) and are identical to those cleared under K141594. As such, performance testing is not required.