(133 days)
Not Found
No
The 510(k) summary describes a set of mechanical laparoscopic instruments and does not mention any AI or ML capabilities. The performance studies are focused on mechanical and electrical safety, cleaning, and sterilization, not algorithmic performance.
No
This device is described as an instrument for cutting, clamping, suturing, and dissecting during surgical procedures, which are interventional actions, not therapeutic ones.
No
Explanation: The device is described as an instrument for cutting, clamping, suturing, and dissecting in laparoscopic procedures, indicating it is an surgical tool rather than a device used for diagnosis.
No
The device description clearly states it consists of a handle and insert assembly with a shaft and end-effector, which are physical hardware components. The performance studies also focus on testing physical attributes like strength, cleaning, sterilization, and electrical safety standards related to hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are described as surgical instruments used within the body during minimally invasive procedures for actions like cutting, clamping, suturing, and dissecting. They also allow for electrosurgical functions.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of substances, or diagnostic purposes based on in vitro testing.
The device is clearly an invasive surgical instrument used for procedural interventions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments consists of a handle and insert assembly. The insert assembly contains a shaft and end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance Test Summary - New Device
Instrument strength: Strength Tests - PASS
Device must be reusable: Cleaning and Sterilization Tests - PASS
Device must maintain pneumoperitoneum: Pneumoperitoneum Test - PASS
Device to meet required electrosurgical safety standards: IEC 60601-1, IEC 60601-2, IEC 60601-2-2, IEC 60601-2-18 - PASS
Device is able to be cleaned and sterilized: AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665 - PASS
Device materials are biocompatible: ISO 10993 - PASS
N/A - No clinical tests were conducted for this submission.
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.
BEMA Endoscopic Monopolar Instruments and Accessories - K102921
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The graphic is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 4, 2017
CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061
Re: K163615
Trade/Device Name: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 28, 2017 Received: May 2, 2017
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 of medical devicerelated 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.
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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 (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" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163615
Device Name
Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
Indications for Use (Describe)
The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.
Type of Use (Select one or both, as applicable)
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)
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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Image /page/3/Picture/0 description: The image shows the CareFusion logo. The logo consists of an orange circle with a white shield inside, and the text "CareFusion" in gray. Below the text, there is a smaller text that says "has joined BD".
510(k) SUMMARY – K163615
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion 2200 Inc. |
| Address | 75 North Fairway Drive |
| Vernon Hills, IL 60061 | |
| Phone number | (847) 362-8094 |
| Fax number | (312) 949-0272 |
| Establishment Registration | |
| Number | 1423507 |
| Name of contact person | Jane Weber |
| Date prepared | 28-APR-2016 |
| DEVICE INFORMATION | |
| Trade or proprietary name | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments |
| Common or usual name | Reusable Laparoscopic Instruments |
| Classification name | Electrosurgical Cutting and Coagulation and Accessories |
| Classification panel | 79 General and Plastic Surgery |
| Regulation | Class II per 21CFR 878.4400, Product code GEI |
| Product Code(s) | Multiple devices |
| Legally marketed device(s) to | |
| which equivalence is claimed | BEMA Endoscopic Monopolar Instruments and Accessories - |
| K102921, GEI | |
| Reason for 510(k) submission | Launch new 3mm product line |
| Device description | Snowden-Pencer MicroLap 3mm Laparoscopic Instruments |
| consists of a handle and insert assembly. The insert assembly | |
| contains a shaft and end-effector (jaw pattern). There are several | |
| device models that encompass various lengths, diameters and jaw | |
| patterns based on the surgeon's needs. | |
| Intended use of the device | To be used in laparoscopic and other minimally invasive |
| procedures | |
| Indications for use | The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments |
| are indicated to be used in laparoscopic and other minimally | |
| invasive procedures for cutting, clamping, grasping, suturing and | |
| dissecting and to allow high frequency monopolar cutting and | |
| coagulation. |
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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
| COMPARED TO THE PREDICATE DEVICE | ||
|---|---|---|
| Characteristic | Predicate Device | New Device |
| Type of Device | Reusable | Reusable |
| Intended for direct patient | ||
| contact? | Yes | Yes |
| Intended for extended | ||
| use? (more than 24 hrs) | No | No |
| Active component | Monopolar | Monopolar |
| Length | 18cm, 21cm, 33cm | 24cm and 36cm |
| Diameter | 3mm | 3mm |
| Overall device design | Two-Piece Modular System | Two-Piece Modular System |
| Handle design | Ring and In-Line | Ring, Pistol-Grip and In-Line |
| Insert Assembly End | ||
| Effectors (jaw patterns) | Scissors | |
| Graspers | ||
| Dissectors | ||
| Needle Holders | Scissors | |
| Clamps | ||
| Graspers | ||
| Dissectors | ||
| Needle Holders | ||
| Rated Voltage | 2 kVp in cutting/coagulation | |
| 3 kVp in spray | 1.5 kVp in all modes | |
| Materials | Stainless Steel (SS) | |
| Raydel (Poylphenlsufone – PPSU) | ||
| Tungsten Carbide | ||
| Silver Braze | ||
| 3M DP490 | ||
| Halar S | ||
| Nylon | Stainless Steel | |
| Radel (Poylphenlsufone – PPSU) | ||
| Tungsten Carbide | ||
| Silver braze | ||
| 3M DP490 | ||
| Marabu Tampapur TPU 970 – | ||
| White | ||
| Loctite | ||
| Santoprene | ||
| EPDM Rubber | ||
| Kraton | ||
| How Supplied | Non-Sterile | Non-Sterile |
| Sterilization Modalities | Pre-vacuum Steam | Pre-Vacuum Steam |
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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 | ||
| Device must be reusable | Cleaning and Sterilization Tests | PASS | ||
| Device must maintain | ||||
| pneumoperitoneum | Pneumoperitoneum Test | PASS | ||
| Device to meet required | ||||
| electrosurgical safety standards | IEC 60601-1, IEC 60601-2, IEC 60601-2-2, | |||
| IEC 60601-2-18 | PASS | |||
| Device is able to be cleaned and | ||||
| sterilized | AAMI TIR12, AAMI TIR30, ANSI AAMI | |||
| ST79, ANSI AAMI ST81, ISO 11138, ISO | ||||
| 17664, ISO 17665 | PASS | |||
| Device materials are | ||||
| biocompatible | ISO 10993 | PASS |
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF 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 MicroLap 3mm Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.