(287 days)
Not Found
No
The summary describes mechanical laparoscopic instruments and does not mention any AI or ML components or functions.
No
The device is described as an instrument for transmitting force during surgery, not for directly treating a condition or disease.
No.
The device is described as surgical instruments designed to transmit force for cutting, clamping, grasping, suturing, and dissecting during minimally invasive surgeries. There is no mention of the device collecting or analyzing data for diagnostic purposes; its function is purely interventional.
No
The device description clearly states it consists of physical components (handle, shaft, insert, end-effector) and the performance studies focus on physical properties like strength and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are designed to "transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries." This describes a surgical instrument used on a patient during a procedure.
- Device Description: The description details the physical components of a surgical instrument (handle, shaft, insert, end-effector).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, not to directly interact with the body during surgery.
N/A
Intended Use / Indications for 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.
Product codes
GCJ
Device Description
Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an 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
Performance Test Summary - New Device
- 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 shafts and inserts: Handle ability to connect to worst case shafts and inserts, 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
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
1
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 (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 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 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. |
| Vernon Hills, IL 60061 | |
| Phone number | (847) 362-8094 (Jane Weber) |
| Fax number | (312) 949-0272 (Jane Weber) |
| Establishment | |
| Registration Number | 1423507 |
| Name of contact person | Jane Weber, MS, Regulatory Affairs Manager |
| jane.weber@carefusion.com | |
| Date prepared | 27-JAN-2016 |
| DEVICE INFORMATION | |
| Trade or proprietary | |
| name | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip |
| 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 | |
| device(s) to which | |
| equivalence is claimed | Snowden-Pencer Inc. - Reusable Laparoscopic Instruments - K930667, |
| GCJ | |
| Reason for 510(k) | |
| submission | Design modification to allow device to be taken apart |
| Device description | Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip |
| Laparoscopic Instruments consists of a handle, shaft and insert. The | |
| insert contains an 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 | Cutting, clamping, grasping, suturing and dissecting |
| Indications for 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. |
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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 | ||
| contact? | Yes | Yes |
| Intended for extended | ||
| use? (more than 24 hrs) | No | No |
| Cleaning Method | Manual and Automatic | Manual and Automatic |
| Sterilization Method | Product is sold non-sterile and | |
| sterilized by the end user via the | ||
| following steam sterilization options: | ||
| • Gravity Displacement | ||
| • Prevacuum | Product is sold non-sterile and | |
| sterilized by the end user via | ||
| the following steam sterilization | ||
| options: | ||
| • Prevacuum | ||
| Materials | Stainless Steel | |
| Aluminum | ||
| Radel-R | ||
| Halar | ||
| Tungsten Carbide | Stainless Steel | |
| Radel-R | ||
| Halar | ||
| Tungsten Carbide | ||
| Handle Configuration | Ring Handle, In-Line handle, and Pistol Grip (bent) | In-Line handle and Pistol Grip |
| (bent) | ||
| Shaft/End Effector | ||
| 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 | ||
| Patterns) | Scissors, Graspers, Dissectors, | |
| Clamps and Needle Holders | Scissors, Graspers, Dissectors, | |
| 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 | ||
| shafts and inserts | Handle ability to connect to worst case | |
| shafts and inserts | 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 Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.