(280 days)
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No
The summary describes a purely mechanical device (trocars) and makes no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The 'Intended Use / Indications for Use' section states that the device is designed "to carry out diagnostic and therapeutic measures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is designed "to carry out diagnostic and therapeutic measures."
No
The device description explicitly states it is made of medical grade stainless steel and brass, indicating it is a physical 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 establish access by piercing a vessel or chamber to facilitate insertion of a trocar sleeve for diagnostic and therapeutic measures. This describes a surgical or procedural tool used in vivo (within the body), not a device used to examine specimens in vitro (outside the body).
- Device Description: The description of the device as made of stainless steel and brass, and its function as a piercing tool, aligns with surgical instruments, not IVDs which typically involve reagents, test strips, or analytical equipment for examining biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on testing samples outside the body.
Therefore, this device is a surgical instrument used for access during procedures, not an IVD.
N/A
Intended Use / Indications for Use
The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures.
Product codes
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Device Description
Trocars are made of medical grade stainless steel and brass (satin chromeplated).
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
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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
Trocars have been tested and found to be safe when used in accordance with the intended use as outlined in the Instruction for Use Manual, No clinical tests performed.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
Richard Wolf Medical Instruments Corporation
T . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
OC1ービーニンコロ
OCT 28 1996
Image /page/0/Picture/2 description: The image shows handwritten text. The top line reads 'K960299'. The bottom line reads 'P142'.
353 Corporate Woods Park Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
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510(k) Summary of Safety and Effectiveness
- 1.0 Classification Name: Trocar and Trocar sleeve
- 2.0 Common/Usual Name: Trocar and Trocar sleeve
- Trade Name: 3.0 Pyramidal Trocar with spring-return protective sleeve
4.0 Equivalence:
These devices are equivalent to existing Richard Wolf Pre-enactment Devices and substantially equivalent to existing competitor devices on the market today.
-
5.0 Description:
Trocars are made of medical grade stainless steel and brass (satin chromeplated). -
6.0 Intended Use:
The pyramidal trocars with spring-return protective sleeve are designed for establishing access by piercing a vessel or chamber to facilitate insertion of the trocar sleeve (cannula) to carry out diagnostic and therapeutic measures. -
7.0 Technological Characteristics:
The trocar was specially designed to shield the tip from exposure after introduction.
8.0 Performance Data:
Trocars have been tested and found to be safe when used in accordance with the intended use as outlined in the Instruction for Use Manual,
- 9.0 Clinical Tests: No clinical tests performed.
Image /page/0/Picture/19 description: The image shows the words "RICHARD WOLF" in a bold, sans-serif font. The word "RICHARD" is stacked on top of the word "WOLF". To the right of the words is a logo that appears to be two letters inside of a rounded square. The letters in the logo are stylized and difficult to read.
1
ﺇﻣﺔ ﺃ
Richard Wolf Medical Instruments Corporation
960299
PL012
- 10.0 Data Conclusion
Trocars from Richard Wolf are substantially equivalent to existing instruments on the market.
By: Robert. Ca
Roberto J. Casasa
ースレームーー
Date: October 22 1996
Robert L. Casarsa Quality Assurance Manager