(15 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as an applicator for mixing and spraying liquids onto treatment sites, not as a device that delivers a therapeutic effect itself. Its function is to facilitate the application of other substances.
No
Explanation: The device is described as an applicator designed to mix and spray liquids onto treatment sites. There is no mention of it collecting data, analyzing conditions, or providing information about a patient's health status. It is a tool for delivering treatment, not for diagnosis.
No
The device description clearly outlines physical components made of various materials (Polypropylene, ABS, Stainless Steel, etc.) and describes mechanical testing (bond strength, pull strength, torque strength, leak test, spray test), indicating it is a 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 for the "application of two non-homogenous liquids" by spraying them onto treatment sites within the body. This is a therapeutic or procedural application, not a diagnostic one.
- Device Description: The device is designed to mix and apply substances to the body, not to analyze samples from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or analyze specimens (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the mechanical integrity, functionality (mixing and spraying), and biocompatibility of the device for its intended application, not on diagnostic accuracy or performance metrics like sensitivity or specificity.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device operates in vivo (within the body) for the application of substances.
N/A
Intended Use / Indications for Use
Intended for the application of two non-homogenous liquids.
Product codes
GCJ
Device Description
The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar.
The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts:
- . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately)
- Stainless steel shaft connecting hub to Pebax ●
- Flexible Pebax portion connecting stainless steel shaft to distal tip
- Fixed-position distal tip. ●
Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media.
The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneously or within the body
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)
The Lap Spray Applicator with Spinning Luers was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 –Biological evaluation of medical devices, Part 1 – Evaluation and tests show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life.
Testing was conducted for the following:
- Visual Inspection ●
- . Particulate Matter
- Dimensional Verification Test
- Leak Test
- . Spray Test
- Pebax/Tip Bond Strength
- . Pebax/Shaft Bond Strength
- . Hub/Shaft Pull Strength
- . Hub/Shaft Torque Strength
- Spinning Luer Actuation Torque ●
- Spinning Luer Side Load
- Spinning Luer Pull Strength
- ISO 594-1 and -2 (specifically: Luer Gauge, Luer Leak, Luer Separation, Luer Ease of Assembly, Luer Override, and Luer Stress Cracking)
- Sterilization ●
- Shelf life ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending downward from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2016
Micromedics Inc. (d/b/a Nordson Medical) Ms. Amy Peterson Senior Regulatory Affairs Specialist 1270 Eagan Industrial Rd. Suite 120 St. Paul, Minnesota 55121
Re: K162077
Trade/Device Name: Laparoscopic Spray Applicator with Spinning Luers Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: July 22, 2016 Received: July 27, 2016
Dear Ms. Peterson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Christopher J. Ronk -S
Fox Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162077
Device Name
Laparoscopic Spray Applicator with Spinning Luers
Indications for Use (Describe) Intended for the application of two non-homogenous liquids.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K162077 – 510(K) SUMMARY
Contact Person
Micromedics, Inc.
Date of Summary Preparation: August 10, 2015
510(k) Applicant/Submitter Micromedics, Inc. Amy L. Peterson, M.A. d/b/a Nordson Medical Sr. Regulatory Affairs Specialist 1270 Eagan Industrial Road St. Paul, MN 55121-1385 d/b/a Nordson Medical Tel: 651-452-1977; Fax: 651-452-1787 1270 Eagan Industrial Road Establishment Registration #2183425 St. Paul, MN 55121-1385
| General Information | |||
|---|---|---|---|
| Device Name | Laparoscopic Spray Applicator with Spinning Luers | ||
| Classification | |||
| Information | Endoscope and Accessories | ||
| per 21 CFR 876.1500 (Class II) | Product Code | GCJ | |
| Panel | General & Plastic Surgery | ||
| Predicate | |||
| Device | Micromedics Inc's 360° Gas Assisted Endoscopic Applicator, K122526, cleared | ||
| November 16, 2012. |
Device Description
The Laparoscopic (Lap) Spray Applicators with Spinning Luers are sterile, single-use, disposable devices that are designed to mix two non-homogeneous liquids and to allow the resulting mixture to be applied by spraying on potentially difficult to reach treatment sites subcutaneously or within the body through a trocar.
The Lap Spray Applicator with Spinning Luers consists of a lap spray applicator and a filter/tubing assembly (also called the tubing set). The Lap Spray Applicator with Spinning Luers has the following functional parts:
- . Proximal hub (Y-connection) with spinning luers to connect to dual syringes (not provided) and an attachment point for the filter/tubing to the gas regulator (provided separately)
- Stainless steel shaft connecting hub to Pebax ●
- Flexible Pebax portion connecting stainless steel shaft to distal tip
- Fixed-position distal tip. ●
Lap Spray Applicator components are made from the following materials: White or Blue Polypropylene, Acrylonitrile Butadiene Styrene (ABS - regular/non-radiopaque), Acrylonitrile Butadiene Styrene (ABS) with 20% barium (radiopaque), Stainless Steel, White Nylon, Light Blue Pebax, Epoxy Adhesive. Tubing Set components are made from the following materials: Clear Medical PVC. Natural Nylon, Stainless Steel Wire Mesh, Clear Polycarbonate, Blue Nylon or Red Nylon, Clear Acrylonitrile Butadiene Styrene (ABS), Clear Acrylic, Versapor Filter Media.
The device is packaged in a thermoformed tray with a tray (Tyvek) lid. Five (5) trays are then put into a shelf box and then a cardboard shipper box. Like the device from K122526, the Lap Spray Applicators with Spinning Luers are sterilized using ethylene oxide.
4
K162077 – 510(K) SUMMARY
Intended Use / Indications
Intended for the application of two non-homogenous liquids.
Substantial Equivalence Comparison
The Lap Spray Applicator with Spinning Luers is substantially equivalent to the predicate device in the following characteristics:
- Operational mode
- Basic Scientific Technology .
- . Intended Use
- · General physical characteristics
Summary of Non-Clinical Performance Data
The Lap Spray Applicator with Spinning Luers was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life.
Testing was conducted for the following:
- Visual Inspection ●
- . Particulate Matter
- Dimensional Verification Test
- Leak Test
- . Spray Test
- Pebax/Tip Bond Strength
- . Pebax/Shaft Bond Strength
- . Hub/Shaft Pull Strength
- . Hub/Shaft Torque Strength
- Spinning Luer Actuation Torque ●
- Spinning Luer Side Load
- Spinning Luer Pull Strength
- ISO 594-1 and -2 (specifically: Luer Gauge, Luer Leak, Luer Separation, Luer Ease of Assembly, Luer Override, and Luer Stress Cracking)
- Sterilization ●
- Shelf life ●
Summary of Clinical Performance Data
None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
As evidenced by the successful completion of non-clinical performance testing, the Lap Spray Applicator with Spinning Luers does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.