(35 days)
Not Found
No
The description details a mechanical surgical stapler and does not mention any computational or data-driven features indicative of AI/ML.
No
The device is a surgical tool used for resection, transaction, and the creation of anastomoses, which are procedures, not therapies. Therapeutic devices are typically used to treat or cure a disease or condition.
No
The device description indicates it is a "linear cutter and stapler" used for "resection, transaction, and the creation of anastomoses," which are surgical procedures, not diagnostic ones.
No
The device description clearly outlines a physical, palm-sized linear cutter and stapler that applies titanium staples, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Description: The NiTi HandSTC is a surgical stapler and cutter used directly on tissues within the body during surgery. It physically resects, transacts, and creates anastomoses (connections) of tissues in the alimentary tract.
- Intended Use: The intended use clearly describes a surgical procedure performed in vivo (within the living body).
The description of the device and its intended use are entirely focused on a surgical tool used internally, not on performing tests on samples outside the body.
N/A
Intended Use / Indications for Use
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
Product codes (comma separated list FDA assigned to the subject device)
GDW
Device Description
The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever.
The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm.
The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings
The reloads are available in two sizes:
Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications.
Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
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)
Not Found
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.
K892927, K843603, K892233, K900129
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).
Not Found
§ 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
OCT 1 9 2004
510(K) SUMMARY
HandSTC
510(k) Number KO42492
Applicant's Name:
NiTi Medical Technologies Ltd. 1 Hatzoran st., P.O.Box 8634 Netanya 42506, Israel Tel.: 972-9-865-0610 Fax: 972-9-835-0127
Contact Person:
Orly Maor NiTi Medical Technologies Ltd. 1 Hatzoran St., P.O.Box 8634 Netanya 42506, Israel Tel.: 972-9-865-0610/102 Fax: 972-9-835-0127 orly@nitimed.com
And/or
Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, NW Washington, DC 20004-1109 Tel: (202) 637-5794 Fax: (202) 637-5910
Date Prepared:
September 2004
Trade Name:
HandSTC.
1
Classification Name:
IMPLANTABLE STAPLE
Classification:
The FDA has classified implantable staple as class II device (product code GDW, Regulation No. 878.4750) and they are reviewed by the Division of General and Restorative Devices.
Predicate Devices:
- · Proximate™ TVC55 Linear Cutter and Stapler (Ethicon Endo-Surgery, Inc. USA) cleared under K892927.
- · Multifire GIA 60 stapler (United States Surgical Cooperation, UAS) cleared under K843603.
- · Universal Endo GIA 60 (United States Surgical Cooperation, UAS) originally cleared under K892233 and K900129.
Performance Standards:
No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act.
Intended Use:
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
Device Description:
The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever.
The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm.
2
The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings
The reloads are available in two sizes:
Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications.
Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.
Substantial Equivalence:
Based on validations and performance testing results, NiTi Medical Techologies Ltd. believes that the HandSTC is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping shapes, resembling a person with outstretched arms.
OCT 1 9 2004
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NiTi Medical Technologies Ltd c/o Mr. Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, D.C. 20004
Re: K042492 Trade/Device Name: HandSTC Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: September 3, 2004 Received: September 17, 2004
Dear Mr. Kahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the easy and the enactment date of the Medical Device Amendments, or to conninered processified in accordance with the provisions of the Federal Food, Drug, de vices that nave been require approval of a premarket approval application (PMA). and Cosmeter ree (. 10. (. 10. (. 10.) and the general controls provisions of the Act. The I ou may, dicrororo, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device to such additional controls. Existing major regulations affecting your device can may be subject to back as a substions, 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Drederal statutes and regulations administered by other Federal agencies. You must or any I odetar battler and the end the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of N Fart 8077, abouts (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.
4
Page 2 - Mr. Jonathan S. Kahan, Esq.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your aving equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket notification. The PDA intellig of subtition for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please of If you desire specific advice for your ac no no no 100 %. Also, please note the regulation entitled, coniact the Office of Complance at (210) 216-617 Part 807.97). You may obtain " Misbranding by relefence to premarket noutheans. Incurrently Act from the Division of Small other general Information on your response at its toll-free number (800) 638-2041 or Manufacturers, International and Octoberhett and Consumers of the Courcdrh/dsmaldsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
HandSTC Device Name:
Indications for Use:
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
Division Sign Off
sion Sign. Division of General, Restorative. and Neurological Devices
K042492 510(k) Number