(57 days)
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No
The document describes a powered surgical stapler and its reload, focusing on mechanical and electrical performance, with no mention of AI or ML capabilities.
No.
The device is a surgical stapler used for resection, transection of tissues, and creation of anastomoses, which are surgical procedures, not therapeutic treatments.
No
The device description clearly states its functions as a surgical stapler for resection, transection of tissues, and creation of anastomoses, which are all treatment/surgical actions, not diagnostic ones.
No
The device description explicitly states it is a "Surgical stapler with Powered Handle, delivering implantable titanium staples," indicating it is a hardware device with a powered component. The performance studies also detail testing related to hardware aspects like staple line strength, battery, and electrical safety standards.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures (resection, transection, creation of anastomoses) on tissues within the body. This is an in vivo application, meaning it's used directly on a living organism.
- Device Description: The description details a surgical stapler that delivers implantable staples. This is a surgical instrument, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. IVDs are designed to provide information about a patient's health status through the examination of these samples.
Therefore, the iDrive™ Powered Handle and RALC are surgical devices used in vivo, not IVDs.
N/A
Intended Use / Indications for Use
- iDrive™ Powered Handle: The Covidien iDrive™ Powered Handle, when used with the Covidien™ iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
- iDrive™ RALC: The Covidien iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the Covidien™ iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
Surgical stapler with Powered Handle, delivering implantable titanium staples. The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gastrointestinal, gynecological, and general abdominal and thoracic
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In-vitro and in-vivo testing to support the intended use of this device includes:
- Staple line pull-apart strength test
- Staple formation test
- Staple line burst strength test
- Hemostasis (free bleed time) evaluation
- Air leak test
- Tissue trauma evaluation
- Knife Cutting Performance test
- Product security on Tissue test while clamping and firing
- Autoclave Reliability test
- Egress of material test
- Fire and clamp Shaft peak stall output torque measurement
- Battery and Battery charger tests
Additional bench top testing has been performed and includes testing to the following electrical safety standards:
- IEC 60601-1: 1988 + A1 (1991) + A2 (1995)
- IEC 60601-1-2: 2007
- IEC 60601-1-8: 2006
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Covidien, iDriveC (K073001), Covidien, RALC (K012809), Ethicon, CONTOUR Curved Cutter Stapler (K091322), Covidien, Autosuture TA DST Series Stapler (K013860, K801589)
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.
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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
Covidien IIc (formerly registered as Tyco Healthcare, LP)
K102325
pg 1 of 2
OCT 1 3 2010
510(k) Summary of Safety and Effectiveness
SUBMITTER: Covidien IIc (formerly registered as Tyco Healthcare, LP) 60 Middletown Avenue North Haven, CT 06473 Tel. No .: (203) 492-5000
CONTACT PERSON: Nishith Desai Associate Manager, Regulatory Affairs Covidien IIc Phone: (203) 492-6339 Fax: (203) 492- 5029
August 16, 2010 DATE PREPARED:
TRADE/PROPRIETARY NAME: iDrive™ System
COMMON/USUAL NAME: Implantable, Staple
Surgical devices - Staple, Implantable CLASSIFICATION NAME:
Covidien, iDriveC (K073001) PREDICATE DEVICE(S): Covidien, RALC (K012809) Ethicon, CONTOUR Curved Cutter Stapler (K091322) Covidien, Autosuture TA DST Series Stapler (K013860, K801589)
Surgical stapler with Powered Handle, delivering implantable DEVICE DESCRIPTION: titanium staples.
INTENDED USE:
TECHNOLOGICAL
MATERIALS:
CHARACTERISTICS:
iDrive™ Powered Handle
The Covidien iDrive™ Powered Handle, when used with the Covidien™ iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
iDrive™ RALC
The Covidien iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the Covidien™ iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
The iDrive™ Powered Handle with the iDrive™ Right Angle Linear Cutter delivers 2 rows of surgical staples on each side of the cutting blade, initiated by buttons on the powered handle.
All patient-contacting components of the iDrive™ Powered Handle and iDrive™ Right Angle Linear Cutter are comprised of materials that have been evaluated in accordance with ISO
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