(276 days)
No
The device description and performance studies focus on mechanical function and clip application, with no mention of AI or ML.
Yes.
The device ligates vessels and tubular structures, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is a Clip Applier, used for ligating vessels and tubular structures during surgical procedures by applying titanium clips. Its function is to facilitate a surgical action (ligation) rather than to diagnose a condition.
No
The device description clearly outlines a physical medical device consisting of a handle, trigger, rotational knob, shaft, jaws, and disposable clip cartridges. It is a hardware device used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ligating vessels and tubular structures during endoscopic and laparoscopic surgical procedures. This is a surgical intervention performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a surgical instrument (Clip Applier) and implantable clips used to physically close off vessels. This is a therapeutic or procedural device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.
Product codes
FZP, GDO
Device Description
The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels and tubular structures
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)
- Biocompatibility: The product has passed the biocompatibility tests by following ISO 10993. The contact time for the device is permanent (≥ 30 days) with the body.
- Performance Testing: The Bench report of Disposable Clip Applier indicates the following results. In clip formation test, the clips were all properly formed by the clip applier. In clip gap measurement, there is no significant difference between Taiwan Surgical Corporation (TWSC) and MICROLINE applier. The perpendicular clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily dislodged from the blood vessel. The parallel clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily sliding over the blood vessel. The airtight capability test result reveals that no tested clips applied to silicone tube (3.0 and 2.0 mm O.D.) allowed for any air leakage of both clip Appliers through the air pressure from 15 to 30 PSI.
- Sterilization Verification Testing: The sterilization validation of gamma irradiation for disposable clip applier was successful and had met the requirements of ISO 11137-2:2012 VD max25 method on substantiation of 25kGy as a sterilization dose. This study therefore supports the multiple batch products to be irradiated at the sterilization dose kGy for a SAL of 10 °.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Clip Gap measurement: $0.215\pm0.024$ mm (Candidate Device) vs $0.223\pm0.005$ mm (Predicate Device)
- Perpendicular Clip Pull: $315\pm11$ g (Candidate Device) vs $305\pm11$ g (Predicate Device)
- Parallel Clip Pull: $627\pm41$ g (Candidate Device) vs $622\pm52$ g (Predicate Device)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular text element and a symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
Taiwan Surgical Corporation Ms. Hsiu-Ping Huang Regulatory Specialist 3F., No. 12, Sec. 2. Sheng Yi Rd. Zhubei City, Hsinchu County 30261 Taiwan
Re: K150259
Trade/Device Name: CLIP PLUS Disposable Clip Applier, ML CLIP PLUS Disposable Clip Applier, L Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: FZP. GDO Dated: January 30, 2015 Received: October 5, 2015
Dear Ms. Huang:
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
1
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 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.
Sincerely yours.
David Krause -S
- 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
2
Indications for Use
510(k) Number (if known) K150259
Device Name
CLIP PLUS Disposable Clip Applier, ML CLIP PLUS Disposable Clip Applier, L
Indications for Use (Describe)
The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures .
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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3
510(k) Summary
The Assigned 510(K) Number: K150259 Date Prepared: 11/06/2015
I. SUBMITTER:
Submitter:
TAIWAN SURGICAL CORPORATION
Address: 3F., No.12, Sec.2, ShengYi Rd., Zhubei City, Hsinchu County 302, Taiwan
Phone Number: +886-3-6588129
Fax Number: +886-3-6588355
Contact Person: Ging-Wen Lu
Email: lulu@taiwansurgical.com.tw
Phone Number: +886-3-6588129 ext. 260
Fax Number: +886-3-6588355
II. DEVICE
Trade Name:
- CLIP PLUS™ Disposable Clip Applier, ML .
- CLIP PLUS™ Disposable Clip Applier, L .
Common Name and Classification:
Table 1. Common Name and Classification
| No. | Common Name | Product Code | Classification | Regulation
Section | Panel |
|-----|-------------------------------------------------|--------------|-----------------|-----------------------|---------------------------------|
| 1 | Applier, surgical, clip
and implantable clip | GDO
FZP | I, exempt
II | 878.4800
878.4300 | General &
Plastic
Surgery |
4
III. PREDICATE DEVICE
Predicate Device 1: MICROLINE PENTAX, INC., K013695
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Predicate Device | Manufacturer | 510(k) Number | |
| CLIP PLUSTM | |||
| Disposable Clip | |||
| Applier | Reusable laparoscopic clip | ||
| applier with implantable | |||
| titanium clip | MICROLINE | ||
| PENTAX, INC. | K013695 |
Table 2. Predicate Device Identification
IV. DEVICE DESCRIPTION
The Clip Applier consists of a handle piece and implantable titanium clips. The Clip Applier handle piece consists of a molded handle and trigger, a 360 degrees rotational knob, a cartridge housing shaft and a pair of jaws which provide secured placement of the clip to the desired vessel. The design enables the surgeon to apply several clips during a laparoscopic procedure without the need for withdrawing and reinserting the Clip Applier each time a clip is put in place and closed. The Clip Applier is designed to be used with a black loaded, sterile cartridge supplied in a sterile pouch. The single use disposable clip cartridge sits inside the shaft of the Clip Applier handle piece. While fully squeezing the hand piece trigger, the cartridge is inserted into the shaft through a slot located in the instrument rear.
v. INDICATIONS FOR USE
The use of the product is indicated in endoscopic procedures, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels and tubular structures.
VI. PRODUCT SPECIFICATION
The shaft of the Clip Applier handle piece is sized to fit through 10mm cannula ports and the overall length of the shaft is 300mm for TDC-10-ML while the overall length of the shaft is 350mm for TDC-10-L. For TDC-10-ML, the clip length is 9mm long when closed and the clip
5
depth is 7.5mm; for TDC-10-L, the clip length is 10.5mm long when closed and the clip depth is 9.5mm.
VII. COMPARISION OF TECHNOLOGY CHARACTERISTICS WITH THE PRIDICATE DEVICE
| Features | Candidate Device | Predicate Device | ||
|---|---|---|---|---|
| 1 | Hand | |||
| Piece | Long tube | |||
| diameter | 10mm | 10mm | ||
| 2 | Long tube length | 290mm/340mm | 300mm/350mm | |
| 3 | Staple quantity | 20 | 20 | |
| 4 | Counter | N | Y | |
| 5 | Instructions | Y | Y | |
| 6 | Staple fallen out | |||
| prevention | ||||
| mechanism | N | Y | ||
| 7 | Surgical field | 15° | 15° | |
| 8 | Titanium | |||
| Clip | Staple wire | 0.9x0.6mm | 0.9x0.6mm | |
| 9 | Staple wide | 4.3mm | 4.3mm | |
| 10 | Staple depth | 6.9mm/9.5mm | 6.9mm/9.5mm | |
| 11 | Pinch flat length | 9mm/10.5mm | 9mm/10.5mm | |
| 12 | Function | Clip Formation | Pass | Pass |
| Clip Gap | ||||
| measurement | $0.215\pm0.024$ mm | $0.223\pm0.005$ mm | ||
| Perpendicular | ||||
| Clip Pull | $315\pm11$ g | $305\pm11$ g | ||
| Parallel Clip Pull | $627\pm41$ g | $622\pm52$ g | ||
| Airtight | ||||
| Capability | Pass | Pass | ||
| 13 | Regulatory Classification | class II | class I/class II | |
| 878.4800 | 878.4800 | |||
| 878.4300 | 878.4300 | |||
| Intended use | Use of these products is indicated in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula for the purpose of ligating vessels with Titanium clips. | The Microline reusable laparoscopic clip applier with implantable titanium surgical clip is intended for use to occlude vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. | ||
| 15 | Package | Blister with Tyvek lid | Blister with Tyvek lid |
Table 3. Specification Comparison Table
6
PERFORMANCE DATA VIII.
-
Biocompatibility :
Because the stainless steel and titanium are standard materials for current clip applier on the market, they have been thoroughly tested in the past for biocompatibility. The product has passed the biocompatibility tests by following ISO 10993. The contact time for the device is permanent (≥ 30 days) with the body. -
Performance Testing :
The Bench report of Disposable Clip Applier indicates the following results. In clip formation test, the clips were all properly formed by the clip applier. In clip gap measurement, there is no significant difference between Taiwan Surgical Corporation (TWSC) and MICROLINE applier. The perpendicular clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily dislodged from the blood vessel. The parallel clip pull test shows that the TWSC result is similar with the MICROLINE result suggested that the TWSC clips is not easily sliding over the blood vessel. The airtight capability test result reveals that no tested clips applied to silicone tube (3.0 and 2.0 mm O.D.) allowed for any air
7
leakage of both clip Appliers through the air pressure from 15 to 30 PSI.
- Sterilization Verification Testing:
The sterilization validation of gamma irradiation for disposable clip applier was successful and had met the requirements of ISO 11137-2:2012 VD max25 method on substantiation of 25kGy as a sterilization dose. This study therefore supports the multiple batch products to be irradiated at the sterilization dose kGy for a SAL of 10 °.
IX. CONCULSIONS
The CLIP PLUS™ Disposable Clip Applier with implantable titanium clip has the same intended use and same basic technology as the predicate device, thus is able to achieve same effectiveness and safety as the predicate device.