(251 days)
It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
(1) Endoscopic marking
(2) Hemostasis for
(a) Mucosal/ sub-mucosal defects < 3cm
(b)Bleeding ulcers.
(c)Polyps<1.5cm in diameter,
(d)Diverticula in the colon
(e)Arteries <2 mm
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.
The provided text describes a 510(k) submission for a Disposable Endoscopic Hemoclip (K222146) and compares it to a predicate device (K182556). The submission focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical trials or AI/algorithm performance. Therefore, many of the requested details about acceptance criteria, clinical studies, and AI performance cannot be found in the provided document.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance.
The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it lists the results of various non-clinical (bench) tests and biological evaluations, aiming to show compliance with standards and equivalence to the predicate. The "performance" is generally described as "passed" or "complies with standards."
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | No cytotoxicity (Same as predicate) |
| Irritation (ISO 10993-10) | No irritation (Same as predicate) | |
| Skin Sensitization (ISO 10993-10) | No skin sensitization (Same as predicate) | |
| Acute Systemic Toxicity (ISO 10993-11) | No acute toxicity (Same as predicate) | |
| Pyrogenicity (USP <85>, USP 43 <151>) | Below 20 EU/device (Same as predicate) | |
| Implantation Test (ISO 10993-6) (Clip component only) | Passed (Local effects after implantation) | |
| Chemical Characterization Study (Clip component only) | Conducted | |
| Sterilization | Method (ISO 11135:2014) | Ethylene oxide (Same as predicate) |
| Sterility Assurance Level (SAL) | 10^-6 (Same as predicate) | |
| Ethylene Oxide and Ethylene Chlorohydrin Residuals (ISO 10993-7) | Below specified limits | |
| Packaging & Shelf-life | Seal Leaks in porous medical packaging (ASTM F1929-15) | Passed (by dye penetration) |
| Seal Strength (ASTM F88/F88M-15) | Passed | |
| Integrity of Seals by Visual Inspection (ASTM F1886/F1886M-16) | Passed | |
| Shipping Containers and Systems Performance Testing (ASTM D4169:2016) | Passed | |
| Shelf-life (Accelerated Aging of Sterile Barrier Systems - ASTM F1980 -16) | 3-years validated (supports proposed 5-year shelf-life) | |
| Device Performance (Bench Tests) | Dimension Test | Passed |
| Rotation Test | Passed | |
| Relocation Test | Passed | |
| Mechanical Integrity Test | Passed | |
| Tensile Strength Test | Passed | |
| Release Force Test | Passed | |
| Clamping Strength Test | Passed | |
| MR Safety | Measurement of Magnetically Induced Displacement Force (ASTM F2052-15) | Passed |
| Measurement of Magnetically Induced Torque (ASTM F2213-17) | Passed | |
| Measurement of Radio Frequency Induced Heating (ASTM F2182-19 e2) | Passed | |
| Evaluation of MR Image Artifacts from Passive Implants (ASTM F2119-07(Reapproved 2013)) | Passed |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical study is included in this submission." All tests described are non-clinical (bench tests, biocompatibility, sterilization, packaging, MR safety). Therefore, there is no "test set" in the context of clinical data, sample size for clinical evaluation, or data provenance from a retrospective or prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies or human-in-the-loop performance evaluations were conducted or reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical medical device (hemoclip), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be the specific requirements and specifications defined by the relevant ISO and ASTM standards. For example, for a tensile strength test, the "ground truth" is a defined force threshold that the device must withstand. For sterilization, it's achieving a SAL of 10^-6. These are objective measures against predefined engineering and biological standards.
8. The sample size for the training set
Not applicable, as no clinical studies or AI/algorithm development (with a training set) were conducted or reported.
9. How the ground truth for the training set was established
Not applicable, as no clinical studies or AI/algorithm development were conducted or reported.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
May 1, 2023
Jiangsu Vedkang Medical Science and Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 2000120 CHINA
Re: K222146
Trade/Device Name: Disposable Endoscopic Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL
Dear Diana Hong:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 2023. Specifically, FDA is updating this SE Letter as an administrative correction to update the company name.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shanil Haugen, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices,.
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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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 28, 2023
Jiangsu Horizon Medical Science & Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai. 2000120 CHINA
Re: K222146
Trade/Device Name: Disposable Endoscopic Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: February 16, 2023 Received: February 23, 2023
Dear Diana Hong:
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.
{2}------------------------------------------------
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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Sivakami Venkatachalam -S
for 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
Enclosure
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Indications for Use
510(k) Number (if known) K222146
Device Name Disposable Endoscopic Hemoclip
Indications for Use (Describe)
It is indicated for Endoscopic clip placement within the Gastromtestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
- (1) Endoscopic marking
- (2) Hemostasis for
(a) Mucosal/ sub-mucosal defects < 3cm
- (b)Bleeding ulcers.
(c)Polyps<1.5cm in diameter,
(d)Diverticula in the colon
(e)Arteries <2 mm
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively
| 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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Page 1 of 6
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K222146
-
- Date of Preparation: 02/18/2023
-
- Sponsor Identification
Jiangsu Vedkang Medical Science & Technology Co., Ltd. No. 52, Guoxiang Road, Wujin Economic Development Zone, Changzhou 213149, Jiangsu, P.R. China
Establishment Registration Number: 3013526170
Contact Person: Lin Zhang Position: International Registrar Tel: +86-519-69877755 Fax: +86-519-69877753 Email: rateam@vedkang.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Disposable Endoscopic Hemoclip Common Name: Hemostasis Clipping Device
Regulatory Information Classification Name: Hemorrhoidal Ligator; Classification: II; Product Code: PKL; Regulation Number: 21CFR 876.4400 Review Panel: Gastroenterology/Urology;
Indications for Use:
It is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:
- (1) Endoscopic marking
- (2) Hemostasis for
- (a) Mucosal/ sub-mucosal defects < 3cm
- (b)Bleeding ulcers
- (c)Polyps<1.5cm in diameter
- (d)Diverticula in the colon
- (e)Arteries <2 mm
- (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.
Device Description
The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm.
- ર. Identification of Predicate Device
Predicate Device 510(k) Number: K182556 Product Name: SureClip Repositionable Hemostasis Clip
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6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity
-
ISO 10993-6:2017 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- ア ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delaved-type hypersensitivitv
-
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
-
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
- A ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
-
ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
-
USP <85> Bacterial Endotoxins Test
-
USP 43 <151> Pyrogen Test
- A ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
-
ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
-
ASTM F2182-19 e2, Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance
- A ASTM F2119-07(Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
-
ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems
Performance testing
- The following bench tests were performed on the Disposable Endoscopic Hemoclip:Dimension
- Rotation test
- . Relocation test
- Mechanical integrity test
- Tensile strength test
- Release force test
- Clamping strength test
{7}------------------------------------------------
Above all tests were passed and demonstrated the result can meet the product requirements.
Biocompatibility testing
The biocompatibility evaluation for the proposed device was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020. The following tests were conducted for the clip component of Disposable Endoscopic Hemoclip:
- Cytotoxicity .
- Irritation .
- . Skin Sensitization
- Acute Systemic Toxicity
- Pyrogenicity
- . Implantation Test
- . Chemical Characterization Study
The following tests were conducted for the delivery component of Disposable Endoscopic Hemoclip:
- Cytotoxicity
- . Irritation
- . Skin Sensitization
- . Acute Systemic Toxicity
- . Pyrogenicity
Sterility, Shipping, and Shelf -life
The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life.
. Package integrity test - after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and sterile device.
- . Sterile Barrier Packaging performed on the proposed device:
- Seal Strength ASTM F88/F88-15 O
- Dye penetration ASTM F1929-15 O
- Visual Inspection ASTM F1886/F1886M-16 o
. Shelf-life of 3-years is validated using FDA recognized standard ASTM F1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
-
- Clinical Test Conclusion
{8}------------------------------------------------
No clinical study is included in this submission.
-
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device K182556 | Remark |
|---|---|---|---|
| Product Code | PKL | PKL | Same |
| Regulation Number | 21CFR 876.4400 | 21CFR 876.4400 | Same |
| Indications for Use | It is indicated for Endoscopic clip placement within the Gastrointestinal tract only via a straight or side viewing flexible endoscope for the purpose of:(1) Endoscopic marking:(2) Hemostasis for(a) Mucosal/ sub-mucosal defects < 3cm,(b)Bleeding ulcers.(c)Polyps<1.5cm in diameter,(d)Diverticula in the colon(e)Arteries <2 mm(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively. | The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope for the purpose of:(1) Endoscopic marking,(2) Hemostasis for(a)Mucosal / sub-mucosal defects < 3cm,(b) Bleeding ulcers,(c) Polyps < 1.5cm in diameter,(d) Diverticula in the colon,(e) Arteries < 2 mm(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively | Same |
| Configuration | Delivery system and clip assembly | Delivery system and clip assembly | Same |
| Rotation function | Rotatable | Rotatable | Same |
| Open width | 9mm, 11mm, 13mm and 16mm | 8mm, 11mm and 16mm | Different |
| Minimal working channel | 2.8mm | 2.8mm | Same |
| Working length | 1600mm, 1800mm, 2300mm and 2600mm | 1650mm and 2350mm | Different |
| Single Use | Single Use | Single Use | Same |
| Labeling | Comply with 21 CFR Part 801 | Comply with 21 CFR Part 801 | Same |
| Table 1 Comparison of Technology Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | -------------------------------------------------- |
{9}------------------------------------------------
| Material | |||
|---|---|---|---|
| Clip components | SUS631 Stainless steel | Unknown | Different |
| Sleeve | SUS316F | Unknown | |
| Metal cap | SUS303 Stainless steel | Unknown | |
| Spring sheath | SUS304 | Unknown | |
| Pulling wire component | SUS304 | Unknown | |
| Coating layer | Polyethylene (PE), Ethylene-vinyl Acetate (EVA) and Purple Pigment | Unknown | |
| Protective tube | SUS304 | Unknown | |
| Core rod | Acrylonitrile Butadiene Styrene (ABS) and Thermoplastic Elastomer (TPE) | Unknown | |
| Slider | Acrylonitrile Butadiene Styrene (ABS) and Thermoplastic Elastomer (TPE) | Unknown | |
| Biocompatibility | |||
| Cytotoxicity | No cytotoxicity | Comply with ISO 10993 standards | Same |
| Skin Sensitization | No skin sensitization | ||
| Irritation | No irritation | ||
| Acute Systemic Toxicity | No acute toxicity | ||
| Sub-acute Systemic Toxicity | No sub-acute toxicity | ||
| Sterilization | |||
| Method | Ethylene oxide | Ethylene oxide | Same |
| SAL | 10-6 | 10-6 | Same |
| Endotoxin Limit | 20EU | 20EU | Same |
Conclusion 9.
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, Disposable Endoscopic Hemoclip, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182556.
§ 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.