(59 days)
Not Found
No
The summary describes a purely mechanical surgical stapler/cutter and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
Yes.
Explanation: The device is used for transaction, resection, and creation of anastomosis of internal tissues in various surgical procedures, which are therapeutic interventions.
No
Explanation: The device description states its function is to deliver staples to approximate internal tissues and to resect, transect, and create anastomoses. These are surgical actions, not diagnostic ones.
No
The device description clearly describes physical hardware components (staples, instrument sizes, adjustable staple height) and the performance studies focus on bench testing of mechanical properties, biocompatibility, and sterility, all indicative of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's application in surgical procedures for "transaction and resection of internal tissues," "resection, transection and creation of anastomosis." These are surgical interventions performed on the body, not tests performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a "Disposable Linear Stapler" and "Disposable Linear Cutter" that deliver staples or cut tissue. This is a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely mechanical for surgical purposes.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Disposable Linear Stapler, Model KYFB-30 / 60 / 90
The Disposable Linear Stapler has application throughout the alimentary tract and in thoracic surgery for transaction and resection of internal tissues.
Disposable Linear Cutter, Model KYQII-60 / 80 / 100
The Disposable Linear Cutter has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
General Disposable Linear Stapler
The Disposable Linear Stapler delivers two staggered rows of titanium staples to approximate internal tissues. The instrument is available in three sizes to accommodate different tissues. Staple height is adjustable to compensate for various tissue thickness .The 30 mm instruments create a 30 mm staple line, the 60 mm instruments create a 60 mm staple line, the 90 mm instruments create a 90 mm staple line.
Disposable Linear Cutter
The disposable linear cutter and the cartridge for disposable linear cutter have applications in abdominal gynecological, pediatric and thoracic surgical procedures for resection, transection and creation of anastomosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract, thoracic, abdominal, gynecological, pediatric
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Bench testing was performed to demonstrate the energy to deliver staples and also to remove staples was consistent with the predicate device.
Biocompatibility testing was performed to ensure the stapler and cutters were constructed of material which passes the ISO 10993 benchmarks. The devices successfully passed tests for ISO 10993-1, ISO 10993-3, ISO 10993-5, ISO 10993-6, ISO 10993-10 and ISO 10993-11.
As these products are delivered sterility testing was performed to ensure the sterilization methodology was sufficient and that the packaging kept the for the stated 3 year shelf life. Testing was performed to ISO 11137-1:2006, ISO 11137-2:2006, ISO 11737-1:2006 and ISO 11737-2:2009, ISO 11607-1:2006, ASTM F1929-98 (2004), ASTM F1980-01 and ASTM D3078-02 (2008) with the products successfully passing all tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: April 22, 2012
JUL 16. 2012
Company making the submission: Name - Changzhou Kangdi Medical Stapler Co., Ltd Address - No. 167-5, East Road, Changzhou, Jiangsu, China 213022 Telephone - 86-519-85162780 Fax - 86-519-85139853 Contact - Mr. Fleming Jiang Email - jiangmingfang@kanghui-china.com
Correspondent: Name: Charles Mack Address: 77325 Joyce Way; Echo, Oregon 97826 Telephone: 931-625-4938 Email: charliemack@irc-us.com
Device:
Trade/proprietary names:
Disposable Linear Stapler, Model KYFB Disposable Linear Cutter, Model KYQII
Common Name: Implantable Staple Classification Name: Staple, implantable Predicate Devices:
Linear Stapler:
Ethicon Endo-Surgery, Inc. K020779 The PROXIMATE Reloadable Linear Stapler, Model TL30, TL60, TL90,
TLH30, TLH60, TLH90
Linear Cutter:
Surgical Devices, a global business unit of Tyco Healthcare Group LP (d/b/a Covidien) K111825 DST Series™ GIA™: Auto Suture™ GIA™ Reloadable Stapler, GIA60, GIA80, GIA100
Classifications Names & Citations: 21CFR 878.4520, GDW, Polymer, ENT synthetic-polyamide (mesh or foil material), Class II
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