EndoClot

K162197 · Endoclot Plus Co., Ltd. · GCJ · Jan 18, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162197
• Device Name: EndoClot
• Applicant: Endoclot Plus Co., Ltd.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Jan 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EndoClot® Applicator is intended to assist the delivery of a powdered hemostatic agent to the treatment site in endoscopic surgeries.

Device Story

EndoClot Applicator is a disposable medical device used during endoscopic surgeries to deliver powdered hemostatic agents. The device consists of a catheter, a gas/powder mixing chamber, a connecting tube, and a gas filter. It connects to an external hospital gas source to pneumatically transport the hemostatic powder to the target site. Operated by a physician or trained clinician, the device facilitates localized hemostasis. The system is designed for biocompatibility and is provided sterile. By enabling precise delivery of hemostatic agents, it assists in managing bleeding during endoscopic procedures.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2006, ASTM F756-13), sterility, and performance testing in accordance with FDA guidance and international standards (ISO 11607-1:2006).

Technological Characteristics

Materials: PTFE, PP (applicator); PVC (connecting tube); styrene-butadiene copolymer (gas filter). Energy source: External hospital gas source. Form factor: Catheter-based delivery system. Sterilization: Ethylene Oxide (EO). Packaging: Tyvek and PETG. Connectivity: Standalone, connects to external gas source.

Indications for Use

Indicated for use in endoscopic surgeries to assist in the delivery of a powdered hemostatic agent to a treatment site.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MEDAFOR DIRECT Gas-Assisted Application System (K123325)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv.

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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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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<br>Industrial Park |
| Contact Name: | Hendry Zhang |
| Telephone No.: | 086-512-62605550 |
| Fax No.: | 086-512-62605551 |
| Email Address: | [e-mail] |
| 2. Correspondent's Information | |
| Company Name: | Med-wheat Shanghai |
| Correspondent Name: | Jonathan Hu |
| Telephone No.: | 86-021-65181421 |
| Email Address: | [e-mail] |
| 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<br>Characteristics | Endoclot Applicator | MEDAFOR DIRECT Gas-<br>Assisted Application System in<br>K123325 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GCJ | GCJ |
| Intended Use | The EndoClot® Applicator is<br>intended to assist the delivery of a<br>powdered hemostatic agent to the<br>treatment site in endoscopic<br>surgeries. | The device is intended to assist the<br>delivery of a powdered hemostatic<br>agent to the treatment site in<br>surgical procedures including<br>endoscopic surgeries, using a 5 mm<br>or larger trocar. |
| Product Structure | Applicator(Catheter, gas/powder<br>mixing chamber), connecting<br>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.