(169 days)
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No
The description details a mechanical surgical instrument and does not mention any software, algorithms, or data processing capabilities that would indicate AI/ML.
No
The device is a surgical instrument used to create an entry point during laparoscopic procedures, not to treat a disease or condition.
No
Explanation: The device description states it is a "Surgical Trocar" used to create an entry point for laparoscopic instruments during surgical procedures, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components made of materials like aluminum, stainless steel, polycarbonate, and silicone rubber, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states the device is a "Surgical Trocar" intended for use during surgical procedures (laparoscopy) to create an entry point into the abdominal cavity for surgical instruments. It is a tool used in vivo (within the living body) for surgical access.
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test. Its function is purely mechanical and procedural.
Therefore, the A.S.D. Surgical Trocar is a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy and other abdominal procedures, to create an entry point for laporascopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely quided and entered into the abdominal cavity through the cannula.
Contraindications: The A.S.D. Trocar in not intended for use when endoscopic techniques are contraindicated.
Product codes
78FBQ
Device Description
The A.S.D. Surgical Trocar is a single-use, sterile, temporary, disposable device intended for use during laparoscopy, to create an entry point for laporascopic into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula.
The Trocar consists of: 1) an obturator with a pointed pyramidal tip, 2) a spring-baded safety shield to of the obturator after lissue penetration. 3) a radiolucent cannula (sleeve) with a gasket system to prevent leakage of gas during i setion and withdrawal of instruments 4) an accessory stability thread to help secure the cannula in the body during use. An collional accessory, an obturator adapter is available to be used as a reducer with the 1011mm system. When the adapter is used, 5 mm instruments are accepted into the 10/11mm trocar.
The A.S.D. Trocar is available in the 10/11mm and 5mm sizes. The size of the size of the size of the instrument that can be entered in the trocar. The sleeve lengths available for the 1011mm and 150mm; and for the 5mm trocar are 70 mm and 100mm. The stability threads are available in 38 mm and 51 mm lengths.
The A.S.D. Trocar is made of aluminum, stainless steel, polycarbonate and silicone rubber.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
abdominal cavity
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Requiatory Authority:
Safe Medical Devices Act of 1990. 21 CFR 807.92
Company:
American Surgical Device 41917 Osgood Road Fremont, CA 94539
MAY 1 4 1996
Medical Device Establishment Registration #: pending
Contact: Ms. Liza Burns, Regulatory Consultant Trade Name: A.S.D. Safety Trocar Common Name: Surgical Disposable Trocar Classification Name: Trocar, Gastro-Urology Classification Code: Gastroenterology and Urology 78FBQ
Device Description:
The A.S.D. Surgical Trocar is a single-use, sterile, temporary, disposable device intended for use during laparoscopy, to create an entry point for laporascopic into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula.
The Trocar consists of: 1) an obturator with a pointed pyramidal tip, 2) a spring-baded safety shield to of the obturator after lissue penetration. 3) a radiolucent cannula (sleeve) with a gasket system to prevent leakage of gas during i setion and withdrawal of instruments 4) an accessory stability thread to help secure the cannula in the body during use. An collional accessory, an obturator adapter is available to be used as a reducer with the 1011mm system. When the adapter is used, 5 mm instruments are accepted into the 10/11mm trocar.
The A.S.D. Trocar is available in the 10/11mm and 5mm sizes. The size of the size of the size of the instrument that can be entered in the trocar. The sleeve lengths available for the 1011mm and 150mm; and for the 5mm trocar are 70 mm and 100mm. The stability threads are available in 38 mm and 51 mm lengths.
The A.S.D. Trocar is made of aluminum, stainless steel, polycarbonate and silicone rubber.
The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy Indications for use: and other abdominal procedures, to create an entry point for laporascopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely quided and entered into the abdominal cavity through the cannula.
Contraindications: The A.S.D. Trocar in not intended for use when endoscopic techniques are contraindicated.
Substantially Equivalent Devices:
ﺮ
1
- The ENDOPATH EP SURGICAL TROCAR 2) The U.S. Surgical SURGIPORT
Distributed and Manufactured by:
American Surgical Devices 41917 Osgood Road Fremont, CA 94539 Tel: 510-252-9999