(166 days)
Not Found
No
The description focuses on the mechanical delivery of a powdered agent and does not mention any AI/ML components or functions.
No.
The device is an applicator intended to assist the delivery of a powdered hemostatic agent. The hemostatic agent would be the therapeutic component, not the applicator itself.
No
The device is described as an applicator to deliver a powdered hemostatic agent. Its intended use is to assist in treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components such as an applicator (catheter, gas/powder mixing chamber), connecting tube, gas filter, and a tube connecting to a gas source.
Based on the provided information, the EndoClot® Applicator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries." This describes a device used during a surgical procedure to apply a therapeutic agent directly to a bleeding site within the body.
- Device Description: The description details a system for delivering a powder using gas pressure, designed for use in endoscopic procedures. This aligns with a surgical or therapeutic device, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status or disease. IVD devices are specifically designed for these purposes.
- Anatomical Site: The "treatment site in endoscopic surgeries" refers to a location within the body where a medical intervention is being performed. IVD devices typically interact with samples taken from the body, not directly with internal anatomical sites during surgery.
In summary, the EndoClot® Applicator is a device used for delivering a therapeutic agent during a surgical procedure, which is characteristic of a surgical or therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 EndoClot® Applicator has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which contains the standards including ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2006, ASTM F756-13, ISO11607-1:2006.
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.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 18, 2017
EndoClot Plus Co., Ltd. % Mr. Jonathan Hu Technical Manager Med-wheat (Shanghai) Medical Technology Co., Ltd. Yangpu District, Liaoyuan East Road, Shuangyang First Suite No.33 Room 303 Shanghai, China 200093 CN
Re: K162197
Trade/Device Name: EndoClot Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 15, 2016 Received: December 22, 2016
Dear Mr. Hu:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 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.
Sincerelv.
Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson -S" in a large, sans-serif font. The text is arranged vertically, with "Jennifer R." on the top line and "Stevenson -S" on the bottom line. The background is a light blue color, and the letters are black.
For 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
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Indications for Use
510(k) Number (if known) K162197
Device Name disposable applicator
Indications for Use (Describe)
The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the in endoscopic surgeries.
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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Image /page/3/Picture/1 description: The image shows the logo for EndoClot. The logo is in blue and black, with a red plus sign to the right. The text "EndoClot" is written in a stylized font, with the "E" and "C" in blue and the rest of the letters in black.
Date Prepared: Dec 15th, 2016
510(k) Summary
[As required by 21 CFR 807.92]
1. Submitter's Information
| Name of Sponsor: | EndoClot Plus Co., Ltd. |
|---|---|
| Address: | 101 Room, B8 Building, 218 Xinghu Street, Suzhou |
| Industrial Park | |
| Contact Name: | Hendry Zhang |
| Telephone No.: | 086-512-62605550 |
| Fax No.: | 086-512-62605551 |
| Email Address: | Hendry@endoclot.com |
| 2. Correspondent's Information | |
| Company Name: | Med-wheat Shanghai |
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 86-021-65181421 |
| Email Address: | Jonathan.hu@medwheat.com |
| 3. Trade Name, Common Name, Classification |
| Trade Name: | EndoClot® |
|---|---|
| Common Name: | EndoClot® Applicator |
| Mode Name: | EA230 |
| Regulation Classification | Endoscope Accessories |
| Product Code: | GCJ |
| Classification Panel: | Gastroenterology/Urology |
| Device Class: | II |
4. Identification of Predicate Device(s)
The identified predicates within this submission are as follows:
The MEDAFOR DIRECT Gas-Assisted Application System have been cleared by FDA through 510(k) No. K123325 (Decision Date - Jan 24, 2013).
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5. Description of the Device
EndoClot® Applicator is a medical device composed of applicator (catheter, gas/powder mixing chamber), connecting tube and gas filter, with a tube connecting to gas source in hospital. The device has good biocompatibility. By combining with external gas source, it can deliver the powdered hemostatic agent to the treatment site in endoscopic surgical procedures.
6. Intended Use/Indication for Use
The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.
7. Technological Characteristics
The working situation and environment of EndoClot® Applicator is the same as that of the MEDAFOR DIRECT Gas-Assisted Application System, the technological characteristics of this product is designed to make same as that of the equivalence product. It applies EO sterilization method, which is also same as that of SE product.
| Technological
Characteristics | Endoclot Applicator | MEDAFOR DIRECT Gas-
Assisted Application System in
K123325 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GCJ | GCJ |
| Intended Use | The EndoClot® Applicator is
intended to assist the delivery of a
powdered hemostatic agent to the
treatment site in endoscopic
surgeries. | The device is intended to assist the
delivery of a powdered hemostatic
agent to the treatment site in
surgical procedures including
endoscopic surgeries, using a 5 mm
or larger trocar. |
| Product Structure | Applicator(Catheter, gas/powder
mixing chamber), connecting
tube, gas filter | applicator, tubing set |
| Applicator | PTFE, PP | PTFE, PP |
| Connecting Tube | PVC | PVC |
| Gas Filter | styrene-butadienecopolymer | |
| Shelf Life | 3 years | 3 years |
| Sterilization Method | EO sterilization | EO sterilization |
| Packaging | Tyvek and PETG | Tyvek and PETG |
A comparison of technological characteristics is provided in the following table:
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8. Discussion of Non-clinical Testing
The EndoClot® Applicator has been conducted related non-clinical tests to identify the substantial equivalence from the predicate device. The tests include the concerning of the biocompatibility, sterility and performance, which contains the standards including ISO10993-5:2009, ISO10993-10:2010, ISO10993-11:2006, ASTM F756-13, ISO11607-1:2006.
9. Substantial Equivalence
The EndoClot® Applicator has taken the biocompatibility, sterility and performance testing into concern in accordance to Food and Drug Administration related guidance and recognized international standards. Test data and report information are included in this submission.
10. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, EndoClot Plus Co., Ltd. concludes that disposable applicator is substantially equivalent to predicate devices with regard to safety and effectiveness.