(23 days)
Not Found
N/A
No
The device description and performance studies focus on mechanical aspects and basic visual indicators, with no mention of AI/ML terms or functionalities.
No
The device is used to create pneumoperitoneum for laparoscopic procedures, but it does not directly treat a disease or condition. It is an instrument used in a surgical process.
No
The device is used for insufflation to establish pneumoperitoneum, which is a preparatory step for laparoscopic procedures, not for diagnosing a condition.
No
The device description clearly describes a physical, sterile, disposable needle with mechanical components (spring-loaded obturator, slide switch) and a luer lock connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The description details a needle designed for physical insertion and gas delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of reagents, assays, or any other components typically associated with IVD devices.
Therefore, the Pneumo-Matic Insufflation Needle is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
Product codes
Not Found
Device Description
The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity
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
The following biocompatibility tests were performed on the Pneumo-Matic Insufflation Needle:
- Cytotoxicity Test
- USP Systemic Toxicity in the Mouse
- USP Intracutaneous Toxicity Study in the Rabbit
- Hemolysis Test
The following safety and performance tests were performed on the Pneumo-Matic Insufflation Needle:
- Tip Pull Test
- Switch operation
- Spring Obturator Operation
- Needle Puncture Test
Key Metrics
Not Found
Predicate Device(s)
Dexide, Inc. Pneumo-Needle
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Apple Medical Corp.
510(k) Premarket Notification
MAR 2 7 1997
K970788
February 20, 1997
Pneumo-Matic Insufflation Needle
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Apple Medical Corp. is required to submit with this Premarket Notification either an "... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Apple Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | Pneumo-Matic Insufflation Needle |
|---|---|
| Owner/Operator: | Apple Medical Corporation |
| 580 Main Street | |
| Bolton, MA 01740 | |
| Registration # 1221923 | |
| Manufacturing Site: | GEOTEC |
| 2800 Post Road, Unit #3 | |
| Warwick, RI 02886 | |
| Device Generic Name: | Spring-loaded pneumoperitoneum needle |
| Classification: | According to Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, the device classification is Class II, Performance Standards (21 | |
| CFR 884.1730). | |
| Predicate Device: | Dexide, Inc. Pneumo-Needle |
| Manufactured and Distributed by: | |
| Dexide, Inc. | |
| 7509 Flagstone Drive | |
| Fort Worth, TX 76181 |
Product Description:
15
The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.
Indications for Use:
The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
1
Biocompatibility:
The following biocompatibility tests were performed on the Pneumo-Matic Insufflation Needle:
-
- Cytotoxicity Test
- USP Systemic Toxicity in the Mouse 2.
-
- USP Intracutaneous Toxicity Study in the Rabbit
-
- Hemolysis Test
Safety and Performance:
The following safety and performance tests were performed on the Pneumo-Matic Insufflation Needle:
-
- Tip Pull Test
-
- Switch operation
- Spring Obturator Operation 3.
-
- Needle Puncture Test
Conclusion:
Based on the indications for use, technological characteristics and performance testing, the Apple Medical Pneumo-Matic Insufflation Needle has been shown to be safe and effective for its intended use.