(25 days)
Not Found
No
The description focuses on the mechanical design and function of a device for delivering hemostatic agents, with no mention of AI or ML capabilities.
No.
The device is an applicator for delivering hemostatic agents, but it does not directly perform a therapeutic function itself. Its purpose is to facilitate the delivery of another agent that performs the therapy.
No
The device is intended for delivering hemostatic agents to bleeding surgical sites, which is a therapeutic function, not a diagnostic one. It doesn't identify or analyze a condition.
No
The device description clearly outlines physical components (cannula, stylet, packaging) and mentions sterilization and mechanical testing, 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 is to "deliver hemostatic agents to bleeding surgical sites." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical characteristics and function of a device used for delivering a substance during surgery. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies listed (leak testing, particulate testing, mechanical tests, biocompatibility) are typical for a surgical device, not an IVD. IVD performance studies would focus on analytical and clinical performance related to the diagnostic information provided.
Therefore, the Malleable Tip Endoscopic Applicator is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable device intended for delivering a hemostatic agent to bleeding sites. The Malleable Tip Endoscopic Applicator is the identical to predicate with the addition of a malleable tip at the distal end which allows directional placement of hemostatic agents.
The Malleable Tip Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use. This is the identical packaging configuration as the previously cleared device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bleeding surgical sites
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 Malleable Tip Endoscopic Applicator 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 (2009) 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 over the labeled shelf life.
- Leak Testing .
- Particulate Testing .
- . Volume Test
- . Cannula Tissue Compliance
- Hemostatic Agent Multi-Use .
- Shelf life Evaluation ●
- . Kink Test
- Pinch Test .
- Bounce Back Test .
- Flexible Tip Strength .
- Sterilization Validation .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Endoscopic Applicator, K120608, 360° Gas Assisted Endoscopic Applicator, K122526
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Micromedics, Inc.
Special 510(k) Premarket Notification Malleable Tip Endoscopic Applicator
510(K) SUMMARY
JAN 8 2013
Date Prepared: December 5, 2012
| 510(k) Submitter | Contact for Official Correspondence | |
|---|---|---|
| Micromedics, Inc. | Jodi L. Raus, MBA, RAC | |
| 1270 Eagan Industrial Road | Tel: 651-452-1977; Fax: 651-452-1787 | |
| St. Paul. MN 55121-1385 | Email: jodi.raus@nordsonmicromedics.com |
| General Information | |||
|---|---|---|---|
| Trade Name | Malleable Tip Endoscopic | ||
| Applicator | Common Name | Endoscopic Applicator | |
| Classification | |||
| Information | Endoscope and accessories | ||
| per 21 CFR 876.1500 (Class II) | Product Code | GCJ | |
| Panel | General & Plastic Surgery | ||
| Predicate | |||
| Devices | Endoscopic Applicator, K120608 cleared on March 15, 2012 | ||
| 360° Gas Assisted Endoscopic Applicator, K122526, cleared on November 16, 2012 |
Device Description
The Malleable Tip Endoscopic Applicator is a sterile, single-use, disposable device intended for delivering a hemostatic agent to bleeding sites. The Malleable Tip Endoscopic Applicator is the identical to predicate with the addition of a malleable tip at the distal end which allows directional placement of hemostatic agents.
The Malleable Tip Endoscopic Applicator cannula and stylet are packaged in a double sterile barrier tray configuration and sterilized using ethylene oxide. Six individually sterile packaged applicators are contained in a shelf carton along with instructions for use. This is the identical packaging configuration as the previously cleared device.
Intended Use / Indications
The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar
Substantial Equivalence Comparison
The endoscopic applicator subject to this special 510(k) incorporates a flexible tube at the distal end of the applicator which allows for directional positioning of the tip.
1
Summary of Non-Clinical Performance Data
The Malleable Tip Endoscopic Applicator 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 (2009) 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 over the labeled shelf life.
- Leak Testing .
- Particulate Testing .
- . Volume Test
- . Cannula Tissue Compliance
- Hemostatic Agent Multi-Use .
- Shelf life Evaluation ●
- . Kink Test
- Pinch Test .
- Bounce Back Test .
- Flexible Tip Strength .
- Sterilization Validation .
Substantial Equivalence Conclusion
The Malleable Tip Endoscopic Applicator does not raise new questions of safety or effectiveness when compared to the predicate device and is, therefore, substantially equivalent.
- The remainder of this page intentionally left blank .-
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, with three wave-like shapes below it.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Micromedics, Incorporated % Ms. Jodi L. Raus Director of Regulatory, Clinical and Quality Affairs 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121
January 8, 2013
Re: K123847
Trade/Device Name: Malleable Tip Endoscopic Applicator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 14, 2012 Received: December 14, 2012
Dear Ms. Raus:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Ms. Jodi L. Raus
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Micromedics, Inc.
Special 510(k) Premarket Notification Malleable Tip Endoscopic Applicator
Indications for Use
510(k) Number (if known): ___K123847
Malleable Tip Endoscopic Applicator Device Name:
Indications for Use:
The Malleable Tip Endoscopic Applicator is intended for use in delivering hemostatic agents to bleeding surgical sites through a 5 mm or larger trocar.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dwight Yen 2013.01.08 14:01:50 -05'00'
(Division Sign-off) Division of Surgical Devices 510(k) Number K123847