JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD

K132472 · Justright Surgical, LLC · GDW · Feb 11, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K132472
• Device Name: JUSTRIGHT 5MM STAPLER, JUSTRIGHT 5MM RELOAD
• Applicant: Justright Surgical, LLC
• Product Code: GDW · General, Plastic Surgery
• Decision Date: Feb 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4750
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 Story

JustRight 5mm Stapler System is a manual, reloadable surgical instrument designed for endoscopic use through 5mm cannula sleeves. Device features a 360° rotating shaft and integrated knife blade. Operation involves clamping tissue, placing two 25mm staggered rows of titanium staples, and simultaneously dividing tissue between rows. Used by surgeons in OR settings for abdominal, gynecologic, pediatric, and thoracic procedures. Provides atraumatic tissue clamping and safety lock mechanism. Benefits include smaller incision requirements (5mm vs 12mm) compared to larger predicate staplers, facilitating minimally invasive access while maintaining staple line integrity and performance equivalent to larger devices.

Clinical Evidence

Bench testing only. In vitro testing evaluated device durability, staple formation, and actuation/reload performance. In vivo testing compared the device to the predicate, assessing tissue trauma, knife cutting performance, staple formation, and staple line integrity (burst testing). Biocompatibility testing was conducted per ISO 10993.

Technological Characteristics

Manual, reloadable endoscopic stapler. Materials: Titanium (ASTM F67-06) staples. Dimensions: 5mm shaft diameter, 20cm shaft length, 30mm cartridge length, 25mm staple line. Features: 360° rotation, integrated knife, safety lock. Sterilization: Ethylene Oxide (SAL 10^-6).

Indications for Use

Indicated for patients undergoing abdominal, gynecologic, pediatric, or thoracic surgery requiring tissue resection, transection, or anastomosis creation.

Regulatory Classification

Identification

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• Covidien Endo GIA™ 30mm 2.0 Size Staple (K892233)

Submission Summary (Full Text)

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## 510(K) SUMMARY

K132472

## Submitter Information

| | Submitter's Name:<br>Address:<br>Boulder, | JustRight Surgical LLC<br>6235 Gunpark Drive #G<br>CO 80301 | FEB 1 1 2014 | |
|-------------------------------------------|-------------------------------------------|-------------------------------------------------------------|--------------|--|
| | Telephone:<br>Fax: | 720-287-7130<br>720-287-7130 | | |
| | Contact Person:<br>Telephone: | Michele Lucey<br>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:<br>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.

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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™ 5mm<br>Stapler System | Covidien Endo GIA™ | Comments on<br>Differences |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GDW, GAG | Same | |
| Regulation<br>Number | 878.4750 | Same | |
| Regulation Name | Implantable Staple | Same | |
| Implantable<br>Staple Material | Titanium (ASTM F67-06) | Same | |
| Intended Use | Intended for use in<br>abdominal, gynecologic,<br>pediatric and thoracic<br>surgery for resection,<br>transection and creation | Same | |
| Device Feature | JustRight™ 5mm<br>Stapler System<br>of anastomosis | Covidien Endo GIA™ | Comments on<br>Differences |
| Anatomical Sites | Abdominal and thoracic<br>procedures | Same | |
| Unformed staple<br>leg length | 2mm | Same | |
| Staple wire<br>diameter | .2mm | Same | |
| Staple shape | B shaped | B shaped | |
| Staple Image | Image: JustRight Staple | Image: Covidien Endo GIA Staple | |
| Indicated tissue<br>thickness | .75-1.0mm | Same | |
| Cartridge length | 30mm | 50mm | Overall size does not<br>affect function |
| Staple line<br>length | 25mm | 30mm | The difference in length<br>limits the flattened<br>length for transection |
| Number of<br>staples per line | 6 | 8 | The difference in length<br>limits the flattened<br>length for transection.<br>The number of staples<br>per mm is the same. |
| Number of staple<br>lines per<br>cartridge | 4 | 6 | Staple line integrity<br>(burst) testing was<br>conducted to compare<br>the JustRight Stapler to<br>the predicate. The<br>results showed<br>equivalence in staple<br>line integrity |
| Device Feature | JustRight™ 5mm<br>Stapler System | Covidien Endo GIATM | Comments on<br>Differences |
| Staple line<br>configuration | Staggered | Same | |
| Operation | Manual | Same | |
| Integrated knife<br>blade to cut<br>between staple<br>line | Yes | Same | |
| Staples beyond<br>knife cut | Yes | Same | |
| Endoscopic use | Yes | Same | |
| Minimum<br>endoscopic<br>cannula size | 5.5mm | 12mm | The cannula size is for<br>compatibility and does<br>not affect function |
| Shaft length | 20 cm | 6,16, and 26 cm | The shaft length of the<br>JustRight Stapler is<br>within the range offered<br>for the predicate |
| Shaft Diameter | 5mm | 12mm | Device performance is<br>not dependent on the<br>shaft diameter. The<br>diameter only means that<br>different sized trocar<br>cannulas are used for<br>insertion. |
| Shaft rotation | 360° | Same | |
| Cartridge<br>articulation | No | Yes | |
| Reloadable | Yes | Same | |
| Reload limits | Up to 15 staple firings per<br>handle | Up to 25 staple firings<br>per handle | The number of staple<br>firings for the JustRight<br>device is reasonable for<br>a single use device and<br>the number of staple |
| Device Feature | JustRight™ 5mm<br>Stapler System | Covidien Endo GIA™ | Comments on<br>Differences |
| | | | firings performed within<br>a single surgical<br>procedure. |
| Safety lock | Yes | Same | |
| Atraumatic tissue<br>clamp | Yes | Same | |
| How Supplied | Sterile single use only | Same | |
| Biocompatibility | Tissue contact materials<br>are biocompatible per<br>ISO 10993 | Same | |
| Sterilization | Ethylene Oxide | Same | |
| Sterility<br>Assurance Level | 10-6 | Same | |
| Endotoxin Limit | 20 EU per Product | Same | |
| Package | Tyvek/Blister Tray | Same | |
| Labeling | Conforms to 21 CFR Part<br>801 | 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 [phone] or [phone] 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 [phone] or [phone] 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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