(138 days)
Not Found
Not Found
No
The device description focuses on mechanical components and functions (puncture, port of access, safety mechanism, seals, valves) and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
No.
This device is designed to create a port of entry for endoscopic instruments during surgery, not to treat a specific medical condition or disease.
No
The device is described as a "Resposable Trocar System" used for establishing a port of entry for endoscopic instruments in surgical procedures. Its function is to facilitate the passage of instruments, not to diagnose a condition or disease.
No
The device description clearly details physical components like obturators, seals, cannulas, handles, and tips, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Resposable Trocar System is used in endoscopic surgery to create a port of entry for surgical instruments. It is a surgical tool used during a procedure on the body, not for analyzing samples outside the body.
- Intended Use: The intended use is for surgical procedures (endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic, or abdominal procedures), not for diagnostic testing of biological samples.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments. During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar, The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm. Device Description-parts and function/concept: The Origin Classic Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision cite. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures.
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)
Not Found
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.
The ORIGIN Sensing Tip Trocar (OMS-T5S, OMS-T10S, OMST1112S)
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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.
0
Image /page/0/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '960936'. The numbers are written in a cursive style, with some of the digits connected to each other.
Resposable Trocar System
Class II
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
This 510(k) Summary details sufficient information to provide an understanding of the basis for a determination of substantial equivalence. For convenience, the summary is formatted pursuant to 21 CFR §807.92. This section may be used, as presented, to provide a substantial equivalence summary to anyone requesting it from the Agency.
21 CFR §807.92 a(1)
Submitter:
- ORIGIN® Medsystems, Inc. 135 Constitution Avenue Menlo Park, CA 94025 (415) 617-5142 contact person: Anthony Durso date prepared: March 6, 1996
JUL 24 1996
21 CFR §807.92 a(2)
| Trade name: | Resposable Trocar System |
|---|---|
| [5mm, 5mm short, 10mm and 12 mm sizes] | |
| Common name: | Reposable Surgical Trocar |
| Classification name: | Laparoscope, Gynecologic and Accessories |
21 CFR 8807.92 a(3)
Identification of predicate(s): Substantial equivalence for the Resposable Trocar System is based on its similarities to predicate device : the ORIGIN Sensing Tip Trocar (OMS-T5S, OMS-T10S, OMST1112S). The Resposable Trocar System, shares the identical intended use, and technological characteristics as the predicate device. The Resposable Trocar System is also identical in materials except for the reusable cannula. It is stainless steel versus a polycarbonate on the 10mm and 12mm and liquid crystal polermer(LCP) on the 5mm cannula of the Sensing Tip Trocar.
21 CFR §807.92 a(4)
Device Description-parts and function/concept: The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic
1
96093 b
ORIGIN Medsystems, Inc. PREMARKET NOTIFICATION Resposable Trocar System
Class II
21 CFR §807.92 a(4)
Device Description-parts and function/concept: continued
instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.
Device Description-parts and function/concept: The Origin Classic Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision cite. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.
2
Class II
Device Description-materials/physical properties: a table of the patient contact component parts, with their respective materials, is provided below.
| Component Name | Material(s) |
|---|---|
| Cannula | stainless steel |
| Obturator Shaft | polycarbonate |
| Obturator Point | stainless steel |
The listed parts are currently being used in existing ORIGIN products, and therefore have been cleared for biocompatibility (safety) and effectiveness.
21 CFR $807.92 a(5)
Intended use and relationship to predicate(s): The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.
During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar,
The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
3
Resposable Trocar System
Class II
CFR $807.92 a(6)
Technological characteristics and relationship to predicate(s): The Resposable Trocar System is substantially equivalent to the Sensing Tip Surgical Trocar previously cleared product. The new device shares the identical technological characteristics as the predicate device. The Reposable Trocar is also identical in materials except for the reusable cannula. It is stainless steel versus a polycarbonate cannula on the 10mm and 12mm and liguid crystal polermer (LCP) on the 5mm Sensing Tip Trocar.
21 CFR §807.92 b
This submission's determination of substantial equivalence is based on similarities to the predicate devices in terms of intended uses, materials, and technological characteristics.
21 CFR §807.92 c
In accordance with the specifications of this subsection, this summary (4 pages) is its own section, and has been clearly identified as such.