Disposable hemoclip

• K Number: K213217
• Device Name: Disposable hemoclip
• Manufacturer: Beijing ZKSK Technology Co.,Ltd
• Date Cleared: 2022-11-14 ( 411 days)
• Product Code: PKL
• Regulation Number: 876.4400

Intended Use

Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects <3cm, Bleeding ulcers, Arteries < 2mm, Polyps < 1.5cm in diameter. Diverticula in the colon, 3 ) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Device Description

The clip is pre-installed at the front of the chuck releaser, the chuck releaser is delivered by the conveyor duct through the endoscope to the Gastrointestinal (GI) tract system finds the bleeding site, thumb ring releases the chuck, so that the clip clamps the bleeding site to stop the bleeding. The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the HC series. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed no more than five times prior to deployment, aiding in repositioning of the clip at the lesion site. There are 30 models of Disposable Hemoclip.The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type. The material is PE, but the other is the same.

Predicate Devices

K201771

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a mechanical device for endoscopic clipping and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes

The device is intended for endoscopic marking, hemostasis, and closure of GI tract luminal perforations, all of which are therapeutic interventions.

Diagnostic

No

This device is used for therapeutic purposes such as hemostasis and closing perforations, not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a clip, chuck releaser, conveyor duct, and delivery system, indicating it is a hardware device used within the GI tract.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Function: The description clearly states that this device is a "Disposable Hemoclip" used for clip placement within the Gastrointestinal (GI) tract. It is a physical device used for mechanical actions like marking, hemostasis (stopping bleeding), and closing perforations.
• Lack of Sample Analysis: There is no mention of this device analyzing any biological samples or providing diagnostic information based on such analysis. Its function is entirely procedural and mechanical within the body.

Therefore, this device falls under the category of a surgical or endoscopic device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects sterility test, ASTM F 1980-16 Standard quidelines for accelerated aging of sterile barrier systems for medical devices, ASTM FI 886/FI886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection, ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration, ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials, ASTM D3078-02(2013) Standard Test Method for Determination of Flexible Packaging Leakage by Bubble Generation, DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized, ASTM D4169-16 Standard practice for performance testing of shipping containers and systems(DC-13,Level II). Dimension test was performed on the proposed device and the test result demonstrated that the device could meet its design specification requirement. Performance test was performed on the proposed device and predicate device and the test result demonstrated that there was no significant difference between them. Tests included Release performance, Clamping force, Get out of the strength, Surface roughness, Hardness, Corrosion resistance, Rotation performance, Repositionability, Hemoclip assembly mechanical integrity, Clamping release force, Open and Close of hemoclip, Reducing substances, Extractable metal content, pH, Evaporation residue, Ultraviolet absorbance, SAL, EO residue, Shelf life, In vitro Cytotoxicity, Intradermal reactivity, Skin Sensitization, Acute Systemic Toxicity, Material-mediated Pyrogens, Sub-acute Systemic Toxicity. All tests met the requirements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K201771

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

November 14, 2022

Beijing ZKSK Technology Co.,Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, Shanghai 200120 CHINA

Re: K213217

Trade/Device Name: Disposable hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: October 9, 2022 Received: October 11, 2022

Dear Boyle Wang:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K213217

Device Name Disposable Hemoclip

Indications for Use (Describe) Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking, 2 ) Hemostasis for: Mucosal/sub-mucosal defects Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K213217

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

1.0 Submitter's information

Company name: Beijing ZKSK Technology Co., Ltd. Address: Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzhou District, Beijing 101105, China Phone Number: 86-13811778090 Fax number: 86-010-63777521

Date of Preparation: Oct.09, 2022

Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

2.0 Device information

Trade name: Disposable Hemoclip

Common name: Hemorrhoidal ligator

Classification name: Hemorrhoidal ligator

Model(s):

HC-10-16526P, HC-10-19526P, HC-10-23026P, HC-11-16526P, HC-11-19526P, HC-11-230/26P, HC-14-165/26P, HC-14-195/26P, HC-14-230/26P, HC-16-165/26P, HC-16-16-230/26P, HC-10-10-165/26, HC-10-195/26, HC-10-230/26, HC-11-165/26, HC-11-195/26, HC-11-14-165/26, HC-14-165/26, HC-14-195/26, HC-14-230/26, HC-16-165/26, HC-16-195/26, HC-16-230/26.

Model difference: There are 30 models of Disposable Hemoclip. The main structure and material of each specification model are completely consistent. The outer tube of the plastic wrap type has one more layer of plastic than that of the ordinary type.

3.0 Classification

Production code: PKL Regulation number: 21CFR 876.4400 Classification: Class II Panel: Gastroenterology/Urology

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4.0 Predicate device information

Manufacturer: Anrei Medical (Hangzhou) Co., Ltd

Single Use Rotatable and Repositionable Hemoclip Device: 510(k) number: K201771

5.0 Intended Use/Indication for Use Statement

Disposable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of:

1. Endoscopic marking.

2. Hemostasis for:

Mucosal/sub-mucosal defects As a supplementary method, closure of GI tract luminal perforations sterility test

ASTM F 1980-16 Standard quidelines for accelerated aging of sterile barrier systems for medical devices

ASTM FI 886/FI886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.

ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials

ASTM D3078-02(2013) Standard Test Method for Determination of Flexible Packaging Leakage by Bubble Generation

DIN 58953-6:2016 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized

ASTM D4169-16 Standard practice for performance testing of shipping containers and systems(DC-13,Level II)

Dimension test was performed on the proposed device and the test result demonstrated that the device could meet its design specification requirement.

Performance test was performed on the proposed device and predicate device and the test result demonstrated that there was no significant difference between them, the test include following items

Items	Test Methodology	Acceptance Criteria	Results
Release the
performance	Prepare a piece of 10cm*10cm
isolated pig stomach tissue,
insert the tissue clamp into the
simulated clamp channel with
a diameter ≥ 2.8mm, after the
clamp assembly extends out of
the clamp channel, align the
clamp with the tissue, move
the slider to the proximal end,
until there is resistance on the
handle, gradually close the
tissue clamp, and then clamp
the tissue and lift it away from
the desktop. (Note: after
feeling resistance, do not
continue to move the slider to
the near end. If you hear a
click, the clip will not reopen).	The clip of the tissue clamp
shall be able to open and
close smoothly, and the
slider shall be pushed and
pulled to successfully
complete the clamping
action.
After the clip assembly is
disengaged from the
device, the remaining part
can be manually removed
from the analog endoscope
tube.
The force to remove the clip
from the endoscope tube is
not more than 5N.	Meet the
requirements
	Continue to move the slider
towards the near end until the
second resistance is reached,
where a second click is felt or
heard. Continue to move the
slider towards the proximal
end until the thumb ring is
reached. After the clip
assembly is released and
disengaged, use the manual
tension machine to hook the
proximal finger ring of the
handle, and pull the outer tube
of the tissue clip and the
adapter out of the simulated
clamp channel.
Clamping force	Fix the ex-vivo pig stomach
tissue on a vise or other
device and keep it still. Push
the slide block of the
conveying device to make the
clip tissue clamp the tissue,
and pull the slide block
towards the near end until the
clip is closed and the clip
assembly is disengaged.
Thread the silk thread through
the small hole at the rear end
of the clamp base, hang a
100g weight on the silk thread,
and rotate the soft tissue
clamp assembly to open and
close repeatedly after 1min.
The soft tissue clamp
assembly shall not be
separated from the tissue.	After the tissue clamp is
used to clamp the isolated
pig stomach tissue, 100g
weight is applied to the
clamp seat, and it shall not
be separated for 1min.	Meet the
requirements
Get out of the
strength	The isolated porcine gastric
tissue was fixed on the lower
side fixture of the electronic
universal testing machine and
kept moveable. The slider of
the delivery device was
pushed so that the clip
clamped the porcine gastric
tissue, and the slider was
pulled hard proximally until the
clip closed. The position of the
slider was kept constant and
the clip was always in a closed
state. The side of the outer
catheter of the tissue clip near
the clip assembly was fixed on
the upper fixture of the
electronic universal testing
machine, and the electronic	The force required to
remove a deployed clip
from the tissue model
should be between 0.9N
and 2.5N.	Meet the
requirements
	universal testing machine was
started to measure.
Surface
roughness	Use sample block comparison
to compare with the measured
surface according to the visual
and tactile senses, and judge
that the measured surface
roughness is equivalent to that
value.	The surface roughness
parameter Ra of clamps
shall not be greater than
0.5µm	Meet the
requirements
Hardness	Carry out the Vickers hardness
test, the indenter is in contact
with the surface of the sample,
and the test force is applied
perpendicular to the test
surface. The test force holding
time is 10-15s	The hardness of the clip
shall be ≥260HV0.2.	Meet the
requirements
Corrosion
resistance	The test piece is immersed
(the immersion height should
not be less than 30mm) and
boil for at least 30 minutes in a
glass beaker filled with boiling
water (4.1); cool it in the test
water for at least 1 hour, then
take the test piece out of the
test water, expose it to the air
for 2 hours, and then dry it.
Wipe the surface of the test
piece vigorously with the cloth	Corrosion resistance of
metal caps and clamps
shall not be lower than
class b requirements of
class b of boiling water test
method.	Meet the
requirements
Rotation
performance	Bend the outer tube for a circle
with a diameter of 20cm, hold
the positioning cap, and then
rotate the handle. Visually
observe that the clip assembly
should rotate smoothly without
jamming. As shown in the
following figure:

Image: Illustration of rotation performance test | Visually observe that the
clip assembly should follow
the handle to rotate 360 °
left and right, and the
rotation should be smooth
without jamming. | Meet the
requirements |
| Repositionability | Prepare a 10cm10cm piece of
isolated pig stomach tissue,
align the clip with the tissue,
move the slider to the proximal
end, until you feel resistance
on the handle, and gradually
close the tissue clip, then
clamp the tissue and lift it
away from the desktop. (Note:
after feeling resistance, do not
continue to move the slider to
the near end. If you hear a
click, the clip cannot be
reopened.) after the operation | The clamp shall be able to
open normally and separate
from the tissue. It shall be
able to withstand repeated
operation for 5 times. | Meet the
requirements |
| | | | |
| | is completed, move the slider
to the far end and repeat the
above operation for 4 times. | | |
| Hemoclip
assembly
mechanical
integrity | Prepare a piece of 10cm10cm
isolated pig stomach tissue,
insert the tissue clamp into the
simulated clamp channel with
a diameter $\geq$ 2.8mm. After the
clamp assembly extends out of
the clamp channel, align the
clamp with the tissue, move
the slider to the proximal end,
until there is resistance on the
handle, and gradually close
the tissue clamp, clamp the
tissue and lift it away from the
table. (Note: after feeling
resistance, do not continue to
move the slider to the near
end. If you hear a click, the clip
will not reopen). Continue to
move the slider towards the
near end until the second
resistance is felt or heard here.
Continue to move the slider
toward the near end until you
reach the thumb ring. | Visually observe that the
clip assembly should fall off
as a whole, and the
connecting parts between
clip assemblies should not
fall off or become loose. | Meet the
requirements |
| Clamping
release force | As shown in the figure below,
fix the handle on one end of
the force measuring machine,
fix the sliding block on the
other end of the force
measuring machine, start the
force measuring machine in
the direction shown in the
figure below, and the
stretching speed is
200mm/min. As a result, the
force separating the clamp
assembly from the outer tube
after biting and locking shall be
greater than 20N
Image: [Diagram of force measuring machine] | The force separating the
clamp assembly from the
outer tube after biting and
locking shall be greater than
20N. | Meet the
requirements |
| Open and Close
of hemoclip | Gently push the slider toward
the far end to open the clip.
Pull the slider towards the near
end to close the clip. | Push the slider towards the
far end, and the clip should
be able to open.
Pull the slider towards the
near end, and the clip shall
be closed.
This method should be able
to withstand repeated
operation for 5 times. | Meet the
requirements |
| | | | |
| Reducing
substances | Preparation of test solution
Take the sample, press 0.2g
sample Add 1ml of water and
extract for 72 hours at
37°C±1°C. Separate the
sample from the liquid, cool to
room temperature, and use it
as the test solution.
Take the same volume of
water and place it in a glass
container, and prepare a blank
control solution in the same
way
Take 10mL of calibrated
potassium permanganate
solution and sodium thiosulfate
solution and dilute to 0.002
mol/L. Add 10 mL of the test
solution to a 250 mL iodine
flask, add 1 mL of dilute
sulfuric acid and 10 mL of
0.002 mol/L potassium
permanganate standard
solution, boil for 3 minutes,
cool rapidly, add 0.1 g of
potassium iodide, close it, and
shake well. Immediately titrate
with the same concentration of
sodium thiosulfate standard
solution to light yellow, add
0.25 mL of starch indicator
solution, and continue to titrate
with sodium thiosulfate
standard solution until it is
colorless. Titrate the blank
control solution in the same
way. | The difference in
consumption of 0.002mol/L
potassium permanganate
solution should be less than
2.0mL as compared to the
same batch of blank control
liquid at the same volume. | 0.9ml |
| Extractable metal
content | Accurately measure 25mL of
the test solution in a 25mL
Nessler colorimetric tube, take
another 25mL Nessler
colorimetric tube, add 25mL
lead standard solution, and
add acetate buffer (pH3 .5)
2mL, then add 2mL of
thioacetamide test solution,
shake well, place for 2min,
observe from above on a white
background, compare the
color depth. If the test solution
develops color, a small
amount of dilute caramel
solution or other non-
interfering colored solution can
be added to the standard
control solution to make it | The total extractable metal
content in the test solution
shall not exceed 5 g/mL,
and the cadmium content
shall be less than 0.1 g/mL | Meet the
requirements |
| | | | |
| | consistent with the color of the
test solution. Then add 2 mL of
thioacetamide test solution to
the test solution and the
standard control solution,
shake well, and place for 2
minutes. Observe from above
on a white background to
compare the shades of color. | | |
| PH | Take the test solution and the
blank control solution, and
measure the pH value with an
acidity meter. The difference
between the two is the test
result. | The PH difference between
the test solution and the
same batch of blank
solution shall not exceed
1.0 | 0.7 |
| Evaporation
residue | The evaporating dish is pre-
dried to constant weight at
105°C. Measure 50 mL of the
test solution into an
evaporating dish, evaporate to
dryness on a water bath, and
dry to constant weight in a
constant temperature oven at
105°C. Determine the blank
control solution in the same
way. | The total amount of dry
residue should not exceed
5mg | 0.56mg |
| Ultraviolet
absorbance | Take the test solution, use a
1cm cuvette with the blank
control solution as a reference
within 5h, and measure the
absorbance within the
specified wavelength range. | Within the wavelength
range of 250nm to 320nm,
the absorbance of the test
solution shall not be greater
than 0.1. | 0.046 |
| SAL | USP31-NF26 sterility tes | ≤10-6 | Aseptic growth |
| EO residue | ISO 10993-7:2008 | ≤10µg/g | 3.72 µg/g |
| Shelf life | ASTM F 1980-16 | 3 years | Meet the
requirements |
| In vitro
Cytotoxicity | ISO 10993-5 Third edition
2009-06-01 | Under the condition of the
test, no potential cytotoxicity | Under the
condition of
the test, no
potential
cytotoxicity |
| Intradermal
reactivity | ISO 10993-10 Third Edition
2010-08-01, | Under the condition of the
test, no potential
intracutaneous reactions | Under the
condition of
the test, no
potential
intracutaneous
reactions |
| Skin Sensitization | ISO 10993-10 Third Edition
2010-08-01, | Under the condition of the
test, no potential
sensitization | Under the
condition of
the test, no
potential
sensitization |
| Acute Systemic | ISO 10993-11:2017 | Under the condition of the | Under the |
| Toxicity | | test, no acute toxicity | condition of
the test, no
acute
toxicity |
| Material-
mediated
Pyrogens | ISO 10993-11:2017 | Under the condition of the
test, no pyrogen | Under the
condition of
the test, no
pyrogen |
| Sub-acute
Systemic
Toxicity | ISO 10993-11:2017 | Under the condition of the
test, no sub-acute toxicity | Under the
condition of
the test, no
sub-acute
toxicity |

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9.0 Clinical Test Conclusion

No clinical study implemented for the Disposable Hemoclip.

10.0 Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device , the Disposable Hemoclip is as safe, as effective, and performs as well as or better than the legally marketed predicate device K201771.