(188 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML terms or capabilities.
No.
The device description and intended use indicate that it is a surgical stapler used for resection, transection, and creating anastomoses, which are surgical procedures, not therapeutic interventions.
No
Explanation: The JustRight™ 5mm Stapler is described as a surgical stapler used for resection, transection, and creating anastomoses, which are therapeutic actions. Its function involves placing staples and dividing tissue, not diagnosing conditions or diseases.
No
The device description clearly outlines a physical stapler with a handle, staple cartridge, and titanium staples, indicating it is a hardware device, not software-only. The performance studies also focus on physical characteristics like durability, staple formation, and tissue interaction.
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 anastomosis) performed on the patient's body (in vivo).
- Device Description: The description details a surgical stapler that physically interacts with tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are used to test samples like blood, urine, or tissue in a laboratory setting to diagnose or monitor conditions. This device is a surgical tool used directly on the patient during surgery.
N/A
Intended Use / Indications for Use
The JustRight™ 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Product codes
GDW, GAG
Device Description
The JustRight™ 5mm Stapler places two 25mm staggered rows of titanium staples while simultaneously dividing the tissue between the two staple rows. The unformed staple size is 2mm from staple backspan to staple leg tip. The system is provided with a stapler handle with one pre-loaded staple cartridge and reload cartridges are provided separately to allow for multiple staple line applications within one surgical procedure. The JustRight™ Stapler is compatible for introduction and use through a 5mm cannula sleeve and the stapler handle has a rotation knob to allow for 360° rotation of the staple cartridge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal, gynecologic, pediatric and thoracic surgery
Indicated Patient Age Range
pediatric
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)
Non-Clinical Performance Data:
In vivo and in vitro testing of the JustRight ™ 5mm Stapler System was performed to evaluate device function and durability in order to demonstrate that the device is safe and effective and performs as intended. The testing conducted is summarized as follows:
- In vitro Testing .
- Device durability (multiple firings)
- Staple formation
- Device actuation and reload performance
- In vivo Testing (includes comparative testing to predicate device to demonstrate . substantial equivalence)
- Tissue trauma evaluation
- Knife cutting performance
- Device actuation and reload performance
- Staple formation
- Staple line integrity
- Biocompatibilty testing was conducted in accordance with ISO 10993. .
The results of these tests demonstrate that the JustRight™ 5mm Stapler System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(K) SUMMARY
Submitter Information
| | Submitter's Name:
Address:
Boulder, | JustRight Surgical LLC
6235 Gunpark Drive #G
CO 80301 | FEB 1 1 2014 | |
|-------------------------------------------|-------------------------------------------|-------------------------------------------------------------|--------------|--|
| | Telephone:
Fax: | 720-287-7130
720-287-7130 | | |
| | Contact Person:
Telephone: | Michele Lucey
603-748-1374 | | |
| Date Prepared: | | December 12, 2013 | | |
| | Device Trade Name: | JustRight™ 5mm Stapler System | | |
| | Classification: | Class II | | |
| Product Code(s): | | GDW, GAG | | |
| Common and Usual Name: Implantable Staple | | | | |
| Classification Name: | | Implantable Staple | | |
| Regulation Number(s): | | 878.4750 | | |
| Predicate Devices:
K900129, K061095, | | Covidien Endo GIATM 30mm 2.0 Size Staple, K892233, | | |
Intended Use:
The JustRight™ 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Device Description/Technological Characteristics:
The JustRight™ 5mm Stapler places two 25mm staggered rows of titanium staples while simultaneously dividing the tissue between the two staple rows. The unformed staple size is 2mm from staple backspan to staple leg tip. The system is provided with a stapler handle with one pre-loaded staple cartridge and reload cartridges are provided separately to allow for multiple staple line applications within one surgical procedure. The JustRight™ Stapler is compatible for introduction and use through a 5mm cannula sleeve and the stapler handle has a rotation knob to allow for 360° rotation of the staple cartridge.
1
Non-Clinical Performance Data:
In vivo and in vitro testing of the JustRight ™ 5mm Stapler System was performed to evaluate device function and durability in order to demonstrate that the device is safe and effective and performs as intended. The testing conducted is summarized as follows:
- In vitro Testing .
- Device durability (multiple firings) ୍
- Staple formation o
- Device actuation and reload performance ୍
- In vivo Testing (includes comparative testing to predicate device to demonstrate . substantial equivalence)
- Tissue trauma evaluation o
- Knife cutting performance ಂ
- Device actuation and reload performance ಂ
- Staple formation o
- Staple line integrity ে
- Biocompatibilty testing was conducted in accordance with ISO 10993. .
The results of these tests demonstrate that the JustRight™ 5mm Stapler System is substantially equivalent to the predicate device.
Substantial Equivalence:
Comparison to predicate device:
| Device Feature | JustRight™ 5mm
Stapler System | Covidien Endo GIA™ | Comments on
Differences |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GDW, GAG | Same | |
| Regulation
Number | 878.4750 | Same | |
| Regulation Name | Implantable Staple | Same | |
| Implantable
Staple Material | Titanium (ASTM F67-06) | Same | |
| Intended Use | Intended for use in
abdominal, gynecologic,
pediatric and thoracic
surgery for resection,
transection and creation | Same | |
| Device Feature | JustRight™ 5mm
Stapler System
of anastomosis | Covidien Endo GIA™ | Comments on
Differences |
| Anatomical Sites | Abdominal and thoracic
procedures | Same | |
| Unformed staple
leg length | 2mm | Same | |
| Staple wire
diameter | .2mm | Same | |
| Staple shape | B shaped | B shaped | |
| Staple Image | Image: JustRight Staple | Image: Covidien Endo GIA Staple | |
| Indicated tissue
thickness | .75-1.0mm | Same | |
| Cartridge length | 30mm | 50mm | Overall size does not
affect function |
| Staple line
length | 25mm | 30mm | The difference in length
limits the flattened
length for transection |
| Number of
staples per line | 6 | 8 | The difference in length
limits the flattened
length for transection.
The number of staples
per mm is the same. |
| Number of staple
lines per
cartridge | 4 | 6 | Staple line integrity
(burst) testing was
conducted to compare
the JustRight Stapler to
the predicate. The
results showed
equivalence in staple
line integrity |
| Device Feature | JustRight™ 5mm
Stapler System | Covidien Endo GIATM | Comments on
Differences |
| Staple line
configuration | Staggered | Same | |
| Operation | Manual | Same | |
| Integrated knife
blade to cut
between staple
line | Yes | Same | |
| Staples beyond
knife cut | Yes | Same | |
| Endoscopic use | Yes | Same | |
| Minimum
endoscopic
cannula size | 5.5mm | 12mm | The cannula size is for
compatibility and does
not affect function |
| Shaft length | 20 cm | 6,16, and 26 cm | The shaft length of the
JustRight Stapler is
within the range offered
for the predicate |
| Shaft Diameter | 5mm | 12mm | Device performance is
not dependent on the
shaft diameter. The
diameter only means that
different sized trocar
cannulas are used for
insertion. |
| Shaft rotation | 360° | Same | |
| Cartridge
articulation | No | Yes | |
| Reloadable | Yes | Same | |
| Reload limits | Up to 15 staple firings per
handle | Up to 25 staple firings
per handle | The number of staple
firings for the JustRight
device is reasonable for
a single use device and
the number of staple |
| Device Feature | JustRight™ 5mm
Stapler System | Covidien Endo GIA™ | Comments on
Differences |
| | | | firings performed within
a single surgical
procedure. |
| Safety lock | Yes | Same | |
| Atraumatic tissue
clamp | Yes | Same | |
| How Supplied | Sterile single use only | Same | |
| Biocompatibility | Tissue contact materials
are biocompatible per
ISO 10993 | Same | |
| Sterilization | Ethylene Oxide | Same | |
| Sterility
Assurance Level | 10-6 | Same | |
| Endotoxin Limit | 20 EU per Product | Same | |
| Package | Tyvek/Blister Tray | Same | |
| Labeling | Conforms to 21 CFR Part
801 | Same | |
2
K132472
3
K132472
4
The JustRight™ 5mm Stapler System and the predicate device, the Endo Gia™ 30 mm 2.0 Stapler, have the same intended use, similar technological characteristics, identical staple size and material, and similar principals of operation. Where there are differences those have been explained in the table above. These differences do not affect substantial equivalence. The JustRight™ 5mm Stapler System is substantially equivalent to the predicate device.
5
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 11, 2014
JustRight Surgical LLC Ms. Michele Lucey Lakeshore Medical Device Consulting, LLC 128 Blye Hill Landing Newbury, NH 03255
Re: K132472
Trade/Device Name: JustRight 5mm Stapler System Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: Class II Product Code: GDW, GAG Dated: December 12, 2013 Received: December 26, 2013
Dear Ms. Lucey:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced aboye 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 Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical
6
Page 2 - Ms. Michele Lucey
device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132472
Device Name JustRight 5mm Stapler System
Indications for Use (Describe)
The JustRight 5mm Stapler is intended for use in abdominal, gynecologic, pediatic and thoracic surgery for resection and creation of anastomosis.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
THE OR FOR FOR FOR EQUISE ONLY AND AND A POLICE OF CONSECTION OF CONSECTION OF THE And Andrew Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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