Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments

K151036 · Carefusion 2200, Inc. · GCJ · Feb 1, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K151036
• Device Name: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments
• Applicant: Carefusion 2200, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Feb 1, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Device Story

Reusable laparoscopic instruments; handle, shaft, and insert assembly; end-effector jaw patterns. Manual operation by surgeons in OR. Transmits mechanical force for cutting, clamping, grasping, suturing, and dissecting. Take-apart design facilitates cleaning and sterilization. Sold non-sterile; steam sterilized by end-user. Benefits include ergonomic handling and improved reprocessing access compared to single-piece designs.

Clinical Evidence

No clinical tests were conducted for this submission. Substantial equivalence is supported by non-clinical bench testing, including instrument strength, pull strength, assembly/disassembly force, reliability, cleaning/sterilization validation per AAMI/ISO standards, and biocompatibility per ISO 10993.

Technological Characteristics

Reusable manual laparoscopic instruments. Materials: Stainless Steel, Radel-R, Halar, Tungsten Carbide. Configurations: In-line and pistol-grip handles; rotatable/non-rotatable shafts (5mm, 10mm diameters). Sterilization: Steam (Prevacuum). Biocompatibility: ISO 10993. Cleaning: Manual and automatic.

Indications for Use

Indicated for patients undergoing minimally invasive plastic or general laparoscopic surgical procedures requiring cutting, clamping, grasping, suturing, or dissection.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Snowden-Pencer Inc. - Reusable Laparoscopic Instruments (K930667)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 1, 2016

CareFusion 2200 Incorporated Ms. Jane Weber, MS Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K151036

Trade/Device Name: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 14, 2015 Received: December 15, 2015

Dear Ms. Weber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K151036

### Device Name

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments

#### Indications for Use (Describe)

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Type of Use (Select one or both, as applicable)

X 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.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## 510(k) SUMMARY – K151036

Image /page/4/Picture/1 description: The image shows the CareFusion logo. The logo features an orange circle with a white shield inside, with a yellow accent on the top left of the shield. To the right of the circle is the text "CareFusion" in a gray sans-serif font. Below the text is the phrase "has joined BD" in a smaller, lighter gray font.

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

| SUBMITTER INFORMATION | |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | CareFusion 2200 Inc |
| Address | 75 N. Fairway Dr.<br>Vernon Hills, IL 60061 |
| Phone number | [phone] (Jane Weber) |
| Fax number | [phone] (Jane Weber) |
| Establishment<br>Registration Number | 1423507 |
| Name of contact person | Jane Weber, MS, Regulatory Affairs Manager<br>[e-mail] |
| Date prepared | 27-JAN-2016 |
| DEVICE INFORMATION | |
| Trade or proprietary<br>name | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip<br>Laparoscopic Instruments |
| Common or usual name | Reusable Laparoscopic Instruments |
| Classification name | Endoscopic and Accessories |
| Classification panel | 78 Gastroenterology and Urology |
| Regulation | Class II per 21CFR 876.1500, Product code GCJ |
| Product Code(s) | Multiple devices |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | Snowden-Pencer Inc. - Reusable Laparoscopic Instruments - K930667,<br>GCJ |
| Reason for 510(k)<br>submission | Design modification to allow device to be taken apart |
| Device description | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip<br>Laparoscopic Instruments consists of a handle, shaft and insert. The<br>insert contains an end-effector (jaw pattern). There are several device<br>models that encompass various lengths, diameters and jaw patterns<br>based on the surgeon's needs. |
| Intended use of the<br>device | Cutting, clamping, grasping, suturing and dissecting |
| Indications for use | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip<br>Laparoscopic Instruments are designed to transmit cutting, clamping,<br>grasping, suturing and dissecting force to working tips in minimally<br>invasive surgeries such as plastic and general laparoscopic procedures. |

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### 510(k) SUMMARY – K151036

### SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

| Characteristic | Predicate Device | New Device |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Type of Device | Reusable | Reusable |
| Intended for direct patient<br>contact? | Yes | Yes |
| Intended for extended<br>use? (more than 24 hrs) | No | No |
| Cleaning Method | Manual and Automatic | Manual and Automatic |
| Sterilization Method | Product is sold non-sterile and<br>sterilized by the end user via the<br>following steam sterilization options:<br>• Gravity Displacement<br>• Prevacuum | Product is sold non-sterile and<br>sterilized by the end user via<br>the following steam sterilization<br>options:<br>• Prevacuum |
| Materials | Stainless Steel<br>Aluminum<br>Radel-R<br>Halar<br>Tungsten Carbide | Stainless Steel<br>Radel-R<br>Halar<br>Tungsten Carbide |
| Handle Configuration | Ring Handle, In-Line handle, and Pistol Grip (bent) | In-Line handle and Pistol Grip<br>(bent) |
| Shaft/End Effector<br>Rotation Capability | Rotatable and Non Rotatable | Rotatable and Non Rotatable |
| Instrument Length | 24cm, 33cm, 36cm, 45cm | 24cm, 33cm, 36cm, 45cm |
| Instrument Diameter | 3.5mm, 5mm, 10mm | 5mm and 10mm |
| End Effectors (Jaw<br>Patterns) | Scissors, Graspers, Dissectors,<br>Clamps and Needle Holders | Scissors, Graspers, Dissectors,<br>Clamps and Needle Holders |
| Device Configuration | Single-piece design | Take-Apart design |

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### PERFORMANCE DATA

### SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

### Performance Test Summary - New Device

| Characteristic | Standard / Test / FDA Guidance | Results Summary |
|--------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------|
| Instrument strength | Strength Tests | PASS |
| Inadvertent disassembly | Pull Strength Test | PASS |
| Ease of disassembly/reassembly | Force Tests | PASS |
| Handle must be reusable | Reliability Test | PASS |
| Handle compatibility with existing<br>shafts and inserts | Handle ability to connect to worst case<br>shafts and inserts | PASS |
| Device is able to be cleaned and<br>sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI<br>ST79, ANSI AAMI ST81, ISO 11138, ISO<br>17664, ISO 17665 | PASS |
| Device materials are<br>biocompatible | ISO 10993 | PASS |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF<br>SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | |

N/A - No clinical tests were conducted for this submission.

### CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical tests demonstrate the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.