The JustRight™ 5mm Stapler is intended for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

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.

AI/ML Overview

The provided FDA 510(k) summary for the JustRight™ 5mm Stapler System (K132472) describes performance data from non-clinical testing rather than human clinical study data. Therefore, many of the typical questions for AI/diagnostic devices regarding acceptance criteria, sample sizes, expert ground truth, and comparative effectiveness studies are not fully applicable in the context of this device and documentation.

However, I can extract the information provided regarding the device's performance and the types of studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion and positive results of the listed non-clinical tests, demonstrating the device is "safe and effective and performs as intended" and "substantially equivalent to the predicate device." Specific numerical criteria are not detailed in this summary, but the types of performance evaluated are.

Acceptance Criterion (Implied)	Reported Device Performance
In vitro Testing
Device durability (multiple firings)	Evaluated successfully (implies meeting durability expectations).
Staple formation	Evaluated successfully (implies correct and consistent staple formation).
Device actuation and reload performance	Evaluated successfully (implies reliable operation and reloading).
In vivo Testing
Tissue trauma evaluation	Evaluated successfully, including comparative testing to predicate (implies acceptable tissue trauma characteristics, comparable to predicate).
Knife cutting performance	Evaluated successfully (implies effective and clean cutting).
Device actuation and reload performance	Evaluated successfully (implies reliable operation and reloading in a live tissue environment).
Staple formation	Evaluated successfully (implies correct and consistent staple formation in a live tissue environment).
Staple line integrity	Evaluated successfully, including comparative burst testing to predicate, showing equivalence (implies the stapled line maintains structural integrity comparable to the predicate device, despite differences in staple count/line length).
Biocompatibility
Biocompatibility in accordance with ISO 10993	Testing conducted successfully. Tissue contact materials are biocompatible per ISO 10993.
Substantial Equivalence (Overall to Predicate device: Covidien Endo GIA™ 30mm 2.0 Size Stapler)	Demonstrated (implies that despite some differences in cartridge length, staple line length, number of staples/line, number of staple lines/cartridge, cannula size, shaft length, shaft diameter, cartridge articulation, and reload limits, the device performs equivalently to the predicate and does not raise new questions of safety or effectiveness).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified in the provided summary. The non-clinical studies involve in vitro and in vivo testing but do not detail the number of units tested or the number of animals (for in vivo).
Data Provenance: The studies are non-clinical (in vitro and in vivo) and conducted by the manufacturer, JustRight Surgical LLC. The country of origin and whether it's retrospective or prospective are not applicable in the typical sense for clinical data, as this refers to lab and animal testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a surgical stapler, and the testing involves objective measurements of mechanical and biological performance (e.g., staple formation, burst strength, tissue trauma). Ground truth is established through standardized test methods and measurements, not expert consensus interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as the "test set" here refers to non-clinical performance evaluations rather than image or diagnostic interpretations requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (surgical stapler), not an AI/diagnostic software, and no human reader studies or MRMC studies were performed or are relevant to its premarket notification.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" for performance is based on objective measurements from specified test methods, engineering specifications, and established biocompatibility standards (e.g., ISO 10993). For in vivo testing, outcomes are measured directly (e.g., tissue trauma, staple line integrity/burst pressure).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is designed and validated through engineering principles and testing.

9. How the ground truth for the training set was established

Not applicable. There is no training set or associated ground truth in the context of this device.

Summary

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510(K) SUMMARY

K132472

Submitter Information

	Submitter's Name:Address:Boulder,	JustRight Surgical LLC6235 Gunpark Drive #GCO 80301
	Telephone:Fax:	720-287-7130720-287-7130
	Contact Person:Telephone:	Michele Lucey603-748-1374
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:

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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™ 5mmStapler System	Covidien Endo GIA™	Comments onDifferences
Product Code	GDW, GAG	Same
RegulationNumber	878.4750	Same
Regulation Name	Implantable Staple	Same
ImplantableStaple Material	Titanium (ASTM F67-06)	Same
Intended Use	Intended for use inabdominal, gynecologic,pediatric and thoracicsurgery for resection,transection and creation	Same
Device Feature	JustRight™ 5mmStapler Systemof anastomosis	Covidien Endo GIA™	Comments onDifferences
Anatomical Sites	Abdominal and thoracicprocedures	Same
Unformed stapleleg length	2mm	Same
Staple wirediameter	.2mm	Same
Staple shape	B shaped	B shaped
Staple Image	Image: JustRight Staple	Image: Covidien Endo GIA Staple
Indicated tissuethickness	.75-1.0mm	Same
Cartridge length	30mm	50mm	Overall size does notaffect function
Staple linelength	25mm	30mm	The difference in lengthlimits the flattenedlength for transection
Number ofstaples per line	6	8	The difference in lengthlimits the flattenedlength for transection.The number of staplesper mm is the same.
Number of staplelines percartridge	4	6	Staple line integrity(burst) testing wasconducted to comparethe JustRight Stapler tothe predicate. Theresults showedequivalence in stapleline integrity
Device Feature	JustRight™ 5mmStapler System	Covidien Endo GIATM	Comments onDifferences
Staple lineconfiguration	Staggered	Same
Operation	Manual	Same
Integrated knifeblade to cutbetween stapleline	Yes	Same
Staples beyondknife cut	Yes	Same
Endoscopic use	Yes	Same
Minimumendoscopiccannula size	5.5mm	12mm	The cannula size is forcompatibility and doesnot affect function
Shaft length	20 cm	6,16, and 26 cm	The shaft length of theJustRight Stapler iswithin the range offeredfor the predicate
Shaft Diameter	5mm	12mm	Device performance isnot dependent on theshaft diameter. Thediameter only means thatdifferent sized trocarcannulas are used forinsertion.
Shaft rotation	360°	Same
Cartridgearticulation	No	Yes
Reloadable	Yes	Same
Reload limits	Up to 15 staple firings perhandle	Up to 25 staple firingsper handle	The number of staplefirings for the JustRightdevice is reasonable fora single use device andthe number of staple
Device Feature	JustRight™ 5mmStapler System	Covidien Endo GIA™	Comments onDifferences
			firings performed withina single surgicalprocedure.
Safety lock	Yes	Same
Atraumatic tissueclamp	Yes	Same
How Supplied	Sterile single use only	Same
Biocompatibility	Tissue contact materialsare biocompatible perISO 10993	Same
Sterilization	Ethylene Oxide	Same
SterilityAssurance Level	10-6	Same
Endotoxin Limit	20 EU per Product	Same
Package	Tyvek/Blister Tray	Same
Labeling	Conforms to 21 CFR Part801	Same

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K132472

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K132472

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K132472

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.

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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

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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

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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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Regulation Number and Section

§ 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.