(29 days)
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Not Found
No
The device description and performance studies focus on mechanical aspects and comparability to predicate devices, with no mention of AI/ML or related concepts.
No.
The device is used to insufflate the peritoneum, which means to inflate it with gas. This is a preparatory step for laparoscopic surgery, allowing for better visualization and working space, rather than directly treating a disease or condition.
No
The device is used to insufflate the peritoneum, a preparatory step for laparoscopic surgery, and its description focuses on mechanical components and safety features. There is no mention of diagnostic functions such as detection, monitoring, or analysis of disease states or bodily functions.
No
The device description clearly outlines physical components (stainless steel needle, plastic handle, spring-loaded safety stylet, stopcock, luer port) and mechanical testing, indicating it is a hardware medical device.
Based on the provided information, the AMR Insufflation Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for insufflating the peritoneum prior to laparoscopic surgery." This is a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a needle and handle for delivering gas into the body. This is a surgical instrument, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The AMR Insufflation Needle's function is purely procedural, facilitating a surgical technique.
N/A
Intended Use / Indications for Use
The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery.
Product codes
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Device Description
The design consists of a 14 gauge stainless steel needle attached to a plastic handle. The Insufflation Needle features a spring loaded safety stylet. The position of the safety stylet may be determined external to the patient by a color coded indicator on the handle. The needle will be made in two lengths, 120 and 150mm and contains a stopcock with a luer port for connection to an insufflation pump.
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
peritoneum
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
Mechanical testing was conducted to verify the safety and functional performance of the AMR Insufflation Needle. All testing demonstrated the Applied Medical Insufflation Needle is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.
Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APPENDIX VII
SEP 2 4 1000
510(k) SUMMARY
| 510(k) NUMBER: | PENDING |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 26051 Merit Circle, Unit# 103 | |
| Laguna Hills, California 92653 | |
| (714) 582-6120 EXT. 310 | |
| CONTACT PERSON: | Howard V. Rowe |
| DATE OF PREPARATION: | August 21, 1996 |
| NAME OF DEVICE: | Applied Medical Insufflation Needle. |
| CLASSIFICATION NAME: | Endoscope Accessories. |
| TRADE NAME: | Not Determined |
SUMMARY STATEMENT: The AMR Insufflation Needle is a disposable device indicated for use for insufflating the peritoneum prior to laparoscopic surgery. The design consists of a 14 gauge stainless steel needle attached to a plastic handle. The Insufflation Needle features a spring loaded safety stylet. The position of the safety stylet may be determined external to the patient by a color coded indicator on the handle. The needle will be made in two lengths, 120 and 150mm and contains a stopcock with a luer port for connection to an insufflation pump.
The Applied Medical Insufflation Needle has the same use methodology, design and indications as the predicate devices. Mechanical testing was conducted to verify the safety and functional performance of the AMR Insufflation Needle. All testing demonstrated the Applied Medical Insufflation Needle is comparable to the predicate devices and introduces no new safety and effectiveness issues when used as indicated.