(787 days)
The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.
The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter.
The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure.
The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed.
The Medscope Biotech Co., Ltd. SOLID CLIP™ Single Use Clip Applier (K221495) demonstrated substantial equivalence to its predicate device through a series of non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison of features and performance between the subject device (SOLID CLIP™ Single Use Clip Applier) and the predicate device (Endo Clip™ II Clip Applier, K143644). While specific acceptance criteria for each test result are not explicitly listed, the "Comparison" column indicates whether the subject device's performance is "Identical" or "Similar" and if it meets the criteria.
| Feature/Performance | Acceptance Criteria (Implied by Predicate) | SOLID CLIP™ Performance | Comparison/Comments |
|---|---|---|---|
| Clip Formation | Pass (Predicate also Pass) | Pass | Identical |
| Clipped Gap | Similar to 0.18 mm (Predicate) | 0.17 mm | Similar |
| Clipped Step Difference | Similar to 0.02 mm (Predicate) | 0.06 mm | Similar (All meet the criteria) |
| Clipped Pull-out Force | Similar to 258 g (Predicate) | 314 g | Identical |
| Clipped Slip Force | Similar to 933 g (Predicate) | 884 g | Similar (All meet the criteria) |
| Airtight Capability | Pass (Predicate also Pass) | Pass | Identical |
| Trigger Initial Force | Similar to 1.7 kg (Predicate) | 2.3 kg | Similar (All meet the criteria) |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the specific functional performance tests (e.g., number of clips tested for formation, gap, pull-out, slip force, airtight capability, or trigger force). The tests are described as "Non-Clinical Test" and "Performance Study (Functional Testing)", indicating in-vitro testing. The data provenance is not specified in terms of country of origin, but it is clear these are non-clinical (laboratory/bench) tests, not human or animal studies for these specific performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is not an AI/software device that requires expert review for ground truth establishment. The performance tests are based on objective physical measurements and comparisons to a predicate device's established performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which is not the case for these non-clinical, objective functional tests.
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 is a medical device (clip applier), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical performance tests, the "ground truth" or reference points are largely based on:
- Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Endo Clip™ II Clip Applier, K143644) serve as a benchmark for comparison.
- Established Engineering/Performance Standards: Implied adherence to good engineering practice and the ability to achieve the intended function safely and effectively.
- Reference Standards: For other tests like biocompatibility, sterilization, and MR compatibility, specific ISO and ASTM standards (e.g., ISO 10993, ISO 11135, ASTM F2052) serve as the "ground truth" for compliance.
8. The sample size for the training set:
Not applicable. This is a medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process.
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July 18, 2024
Medscope Biotech Co., Ltd. Waine Su Sr. Regulatory Affairs Specialist 2F, No. 8, Keyi Street, GuangYuan Technology Park, Zhunan Town, Miaoli County, 35059 Taiwan
Re: K221495
Trade/Device Name: SOLID CLIP™ Single Use Clip Applier Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP Dated: August 3, 2023 Received: August 3, 2023
Dear Waine Su:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Tek N. Tek N. Lamichhane -S Lamichhane -S Date: 2024.07.18 11:44:44
--------------------------------------------------------------------------------------------------------------------------------------Tek N. Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control 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) K221495
Device Name SOLID CLIP Single Use Clip Applier
Indications for Use (Describe)
The SOLID CLIP Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary K221495
1. SUBMITTER
Medscope Biotech Co., Ltd. 2F, No.8, Keyi Street, Guang Yuan Technology Park, Zhunan Town, Miaoli County 35059, Taiwan Phone: +886-3-7580055 Fax:+886-3-7585050 Contact Person: Waine Su, Sr. Regulatory Affairs Specialist Email:wainesu@medscope.com.tw Date Prepared:July 08, 2024
2. DEVICE
| Device Name | SOLID CLIP™ Single Use Clip Applier |
|---|---|
| Trade/Proprietary Name | SOLID CLIP™ |
| Common Name | Clip Applier |
| Regulation Number | 21 CFR 878.4300 |
| Regulation Name | Implantable clip |
| Regulatory Class | Class II |
| Panel | General and Plastic Surgery |
| Product Code | FZP |
3. PREDICATE AND REFERENCE DEVICES
| Predicate Device | Endo Clip™ II Clip Applier, K143644 |
|---|---|
| Company Name | Covidien |
| Reference Device | ENDO CLIPTM III 5mm Clip Applier, K121194 |
| Company Name | Covidien |
| Regulation Number | 21 CFR 878.4300 |
| Product Code | FZP |
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4. DEVICE DESCRIPTION
The SOLID CLIP™ Single Use Clip Applier is a sterile, single patient use device designed for an appropriately sized trocar sleeve or larger sized trocar sleeve with the use of a converter. It consists of a shaft with an outer diameter of 10 or 5 mm and length of 33 cm, a jaw for forming ligating clips, a pistol handle, an actuation trigger, a 360 degrees rotational knob, and a clip counter.
The shaft with outer diameter 10 mm was preloaded 10, 15, 20 ML (Medium-Large) or 10, 15 L (Large) titanium clips, outer diameter 5 mm shaft only preloaded 10, 15 ML (Medium-Large) titanium clips. Squeezing the trigger places a titanium clip in the jaws and closes the jaws to form the clip on the occlusion of the vessel or tubular structure.
The design of SOLID CLIP™ Single Use Clip Applier provides secured placement of the clip to the targeted vessel and enables the surgeon to apply the clips during a laparoscopic procedure without the need for withdrawing and reinserting the device each time a clip is put in place and closed.
| Series | ModelNo. | ShaftLength(mm) | ShaftDiameter(mm) | ClipSize | ClipQ'ty. | ClipDimension(mm) | Image: Clip Dimension W | Image: Clip Dimension H | Image: Clip Dimension L |
|---|---|---|---|---|---|---|---|---|---|
| W | H | L | |||||||
| CA16 | CA165 | 330 | 10 | L | 10 | 4.5 | 9.8 | 11 | |
| CA166 | 330 | 10 | L | 15 | 4.5 | 9.8 | 11 | ||
| CA167 | 330 | 10 | ML | 15 | 4.5 | 7.8 | 9 | ||
| CA168 | 330 | 10 | ML | 20 | 4.5 | 7.8 | 9 | ||
| CA169 | 330 | 10 | ML | 10 | 4.5 | 7.8 | 9 | ||
| CA56 | CA567 | 330 | 5 | ML | 10 | 3.5 | 8.2 | 9 | |
| CA568 | 330 | 5 | ML | 15 | 3.5 | 8.2 | 9 |
5. INDICATIONS FOR USE
The SOLID CLIP™ Single Use Clip Applier is intended for patients undergoing laparoscopic surgical procedures and can achieve dissection and ligation of blood vessels and other tubular structures for radiographic marking.
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6. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PREDICATE DEVICE
SOLID CLIP™ Single Use Clip Applier is compared to the predicate device, Endo Clip™ II Clip Applier (K143644) and also compared to ENDO CLIP™ III 5mm Clip Applier (K121194) which is used as a reference device specifically for its size.
A side-by-side comparison conducted for clip applier performance demonstrates that SOLID CLIP™ Single Use Clip Applier is substantial equivalence to the subject device, the predicate device and the reference device. The subject device has the same intended use and similar technological characteristics with no new questions of safety or effectiveness raised. Detailed discussion is summarized in the below Comparison Charts that provide a side-by-side comparison.
| Features | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Device Name | SOLID CLIP™ Single UseClip Applier (K221495) | Endo Clip™ II Clip Applier(K143644) | |
| Manufacturer | Medscope Biotech Co., Ltd. | Covidien | |
| Regulation Number | 21 CFR 878.4300 | 21 CFR 878.4300 | Identical |
| Regulation Name | Implantable clip | Implantable clip | Identical |
| Regulatory Class | Class II | Class II | Identical |
| Product Code | FZP | FZP | Identical |
| Indications for use | The SOLID CLIP™ Single UseClip Applier is intended forpatients undergoing endoscopicprocedures and can achieveocclusion of vessels and othertubular structures , and forradiographic marking. | The Endo Clip™ II ClipApplier has application inmany types of endoscopicprocedures to achieveocclusion of vessels and othertubular structures, and forradiographic markings. | Identical |
| Contraindications | • The SOLID CLIP™ SingleUse Clip Applier is notintended for contraceptivetubal occlusion, but may beused to achieve hemostasisfollowing transection of thefallopian tube.• Do not use the SOLID CLIP™Single Use Clip Applier on thecentral circulatory system,renal artery, iliac artery, orother vessels which metalligating clips would notnormally be used. | • The device is not intended forcontraceptive tubal occlusion,but may be used to achievehemostasis followingtransection of the fallopiantube.• Do not use the ENDO CLIP™II disposable clip applier onthe central circulatory system,renal artery, iliac artery, orother vessels which metalligating clips would notnormally be used. | Identical |
| Description | • Sterile• Single patient use | • Sterile• Single patient use | Identical |
| Features | Subject Device | Predicate Device | Comparison |
| Disposable | Disposable | ||
| SterilizationProcess | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | 3 years | 5 years | Difference.Performing the shelf-life stability test hasshown not to affectsafety andperformance. |
| Technical specification | |||
| Shaft diameter | 10mm or 5mm | 10mm | Similar.5mm wascompared to thereference device |
| Shaft length | 330mm | 290mm | Similar.Different designfeature to transportthe clips when firingthe trigger |
| Surgical field | 15° | 15° | Identical |
| Configuration | Jaw, shaft, rotation knob,trigger, handle | Jaw, shaft, rotation collar,trigger, handle | Identical |
| Handle and Trigger | Pistol-grip configuration withactuation trigger | Pistol-grip configuration withactuation trigger | Identical |
| Shaft Rotation | 360-degree rotation knob ineither direction | 360-degree rotation collar ineither direction | Similar.Differentmechanism, but thesame purpose |
| Clip Indicator | Yellow block appears when 5or fewer clips remain in thedevice | Yellow bar which appearswhen the applier is empty | Similar.Differentmechanism, but thesame purpose |
| Clip Material | Titanium | Titanium | Identical |
| Clip Size & Quantity | ML : 10, 15, 20pcs;L : 10, 15pcs | ML : 20pcs | Similar.5mm wascompared to thereference device.Large sizerepresents a largerclip length. |
| Clip Open Width | 4.5mm | 4.5mm | Identical |
| Clip Closed Length | ML: 9mm;L: 11mm | ML: 9mm | Similar.Large sizerepresents a largerclip length. |
| Clip Geometry | U-shape | U-shape | Identical |
| Features | Subject Device | Predicate Device | Comparison |
| angle allows vessels to the back of the clip during approximation. | |||
| Last Clip Lockout | Safety interlock feature.The trigger cannot be squeezed shut when the clip is empty to prevent empty jaw closure to damage a structure or vessel. | Safety-interlock handle design | Identical |
| Performance | |||
| Clip Formation | Pass | Pass | Identical |
| Clipped Gap | 0.17 mm | 0.18 mm | Similar |
| Clipped Step Difference | 0.06 mm | 0.02 mm | Similar.All meet the criteria. |
| Clipped Pull-out Force | 314 g | 258 g | Identical |
| Clipped Slip Force | 884 g | 933 g | Similar.All meet the criteria. |
| Airtight Capability | Pass | Pass | Identical |
| Trigger Initial Force | 2.3 kg | 1.7 kg | Similar.All meet the criteria. |
| Package | Blister with Tyvek lid | Blister with Tyvek lid | Identical |
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7. NON-CLINICAL TEST
The following non-clinical tests were provided in support of the substantial equivalence determination.
| No | Test Item | Reference Standard | Results |
|---|---|---|---|
| 1 | Biocompatibility | ISO 10993FDA guidance | Pass |
| 2 | Performance Study(Functional Testing) | N/A | Pass |
| 3 | Performance Study(Animal Testing) | FDA guidance | Pass |
| 4 | Sterilization andStability Testing | ISO 11135ISO 11737-1ISO 11737-2ISO 11607-1ISO 11607-2ASTM F1140ASTM F1929ASTM F88ASTM F1608 | Pass |
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| No | Test Item | Reference Standard | Results |
|---|---|---|---|
| 5 | MR Compatibility Assessment | ASTM F2052ASTM F2213ASTM F2182ASTM F2119 | MR safety informationdisclosed in thelabeling and IFU |
8. CONCLUSIONS
The non-clinical data support SOLID CLIP™ Single Use Clip Applier with implantable titanium clip perform comparably to the predicate device and the reference device to demonstrate similar intended use and technological characteristics and can be able to achieve the same effectiveness and safety as the legally marketed predicate device (K143644).
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.