(98 days)
Not Found
No
The description focuses on the mechanical function and design of the grasping and dissecting tools, with no mention of AI or ML capabilities. The performance studies are also focused on mechanical properties.
No
The device is described as a surgical instrument (graspers and dissectors) used to transmit grasping force, not to treat or diagnose a disease or condition. Its intended use is to aid in surgical procedures.
No
The device, Diamond-Flex® Graspers and Dissectors, is described as transmitting grasping force for surgical procedures. It is an instrument designed for manipulation during surgery, not for diagnosing conditions or diseases.
No
The device description clearly outlines physical components like a handle assembly, elongate shaft, and distal end with a segmented flexible portion and end-effector/jaw pattern, 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 the device is designed for "transmitting grasping force through delicate working tips in both minimally invasive and open surgical procedures." This describes a surgical instrument used on a patient during a procedure.
- Device Description: The description details a surgical tool with a handle, shaft, and end-effector (jaws). This is consistent with a surgical instrument, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, tissue, urine, etc.) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the human body to provide information for medical purposes. This device is a surgical tool used directly in a surgical procedure.
N/A
Intended Use / Indications for Use
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
Each Diamond-Flex® Grasper and Dissector is comprised of a handle assembly, an elongate shaft and a 'distal end' which comprises a segmented flexible portion and the end-effector or jaw pattern.
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Performance Test Summary-New Device
- Characteristic: Maintains pneumoperitoneum
- Standard/Test/FDA Guidance: Pneumo-peritoneum Test
- Results Summary: PASS
- Characteristic: Articulation system strength
- Standard/Test/FDA Guidance: Shape Forming Verification Test
- Results Summary: PASS
- Characteristic: Actuation system strength
- Standard/Test/FDA Guidance: Crimp Strength Test
- Results Summary: PASS
- Characteristic: Instrument to withstand repeated uses
- Standard/Test/FDA Guidance: Repeated Simulated Use Test
- Results Summary: PASS
- Characteristic: Instrument to meet customer needs for grasping, dissecting, and providing sufficient rigidity to the user in the actuated state
- Standard/Test/FDA Guidance: Customer Evaluation Report
- Results Summary: PASS
The results of the non-clinical tests demonstrate the Diamond-Flex® Graspers meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.
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.
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
§ 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.
0
Traditional 510(k) Premarket Notification: Diamond-Flex® Graspers
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to be a stylized representation of a globe or sphere with a checkmark incorporated into the design. The text "CareFusion" is written in a bold, sans-serif font.
K.110257 pg 1 of 3
MAY - 6 2011
510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion Corporation |
| Address | 1500 Waukegan Road MPWM, McGaw Park, IL 60085 USA |
| Phone number | (847) 473-7429 |
| Fax number | (847) 473-7774 |
| Establishment | |
| Registration Number | 1423507 |
| Name of contact person | Jane Weber |
| Date prepared | 01/19/2011 |
| DEVICE INFORMATION | |
| Trade or proprietary | |
| name | Diamond-Flex® Graspers and Dissectors |
| Common or usual name | Reusable Laparoscopic Instrument |
| Classification name | Endoscope and Accessories |
| Classification panel | 78 Gastroenterology and Urology |
| Regulation | Class II per 21CFR 876.1500, Product code GCJ |
| Product Code(s) | 89-0500, 89-0501, 89-0502, 89-0503, 89-0504, 89-0505, 89-0506, 89-0507, |
| 89-0508, 89-0509, 89-0510, 89-0511, 89-4500, 89-4501, 89-4502, 89-4503, | |
| 89-4504, 89-4505, 89-4506, 89-4507, 89-4508, 89-4509, 89-4510, 89-4511 | |
| Legally marketed | |
| device(s) to which | |
| equivalence is claimed | Snowden-Pencer Inc. - Reusable Laparoscopic Instruments - K930667, GCJ |
| Surgical Innovations Limited - EndoFlex 5000 Endoscopic Forceps - | |
| K946239, GCJ | |
| Reason for 510(k) | |
| submission | New Device |
| Device description | Each Diamond-Flex® Grasper and Dissector is comprised of a handle |
| assembly, an elongate shaft and a 'distal end' which comprises a segmented | |
| flexible portion and the end-effector or jaw pattern. | |
| Intended use of the | |
| device | To grasp and dissect |
| Indications for use | Diamond-Flex® Graspers and Dissectors are designed to transmit grasping |
| force through delicate working tips in both minimally invasive and open | |
| surgical procedures. |
1
Traditional 510(k) Premarket Notification: Diamond-Flex® Graspers
Image /page/1/Picture/1 description: The image contains the logo for CareFusion. The logo consists of a circular graphic on the left and the word "CareFusion" on the right. The circular graphic appears to be a stylized representation of a checkmark or a leaf, composed of many small dots.
ﺮ ﺍﻟﻤ
K110257 pg 2 of 3
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED
| TO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristic | Predicate Device | ||
| Snowden-Pencer Inc. | |||
| Reusable | |||
| Laparoscopic | |||
| Instruments - K930667 | Predicate Device | ||
| Surgical Innovations | |||
| Limited EndoFlex 5000 | |||
| Endoscopic Forceps - | |||
| K946239 | New Device | ||
| Type of Device | Reusable | Reusable | Reusable |
| Materials | Stainless Steel | Stainless Steel | |
| Nitinol Alloy | |||
| Santoprene | |||
| Nylon | |||
| PEEK | |||
| Aluminum | |||
| Tungsten Carbide | Stainless Steel | ||
| Nitinol Alloy | |||
| Santoprene | |||
| Nylon | |||
| PEEK | |||
| Aluminum | |||
| Tungsten Carbide | |||
| Length | 24cm, 33cm, 45 cm | 33cm, 25.5cm | 34cm, 45cm |
| Articulating | |||
| component | None | Segmented flexible portion | |
| that articulates to 40° or 90° | Segmented flexible portion | ||
| that articulates to 40° or 90° | |||
| Articulation | |||
| mechanism | None | Rotating Actuation knob to | |
| tighten cable and form | |||
| shape | Rotating Actuation knob to | ||
| tighten cable and form | |||
| shape | |||
| Actuation | |||
| mechanism | Handle operation causes | ||
| opening and closing of | |||
| end effector | Handle operation causes | ||
| opening and closing of end | |||
| effector | Handle operation causes | ||
| opening and closing of end | |||
| effector | |||
| Flush port? | Yes | Yes | Yes |
| Sterilization | |||
| sleeve? | No | Yes | Yes |
| Requires insertion | |||
| through trocar? | Yes | Yes | Yes |
| Form inserted into | |||
| trocar | Not Applicable | Relaxed-unarticulated | Relaxed-unarticulated |
| Grasper patterns | 6 | 10 | 6 (same as K930667) |
2
Traditional 510(k) Premarket Notification: Diamond-Flex® Graspers
Image /page/2/Picture/1 description: The image shows the CareFusion logo. The logo consists of a circular icon on the left and the word "CareFusion" on the right. The icon appears to be a stylized checkmark within a circle, with a fragmented or pixelated effect. The text "CareFusion" is in a bold, sans-serif font.
Pd 3 of 3
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 |
|---|---|---|
| Maintains pneumoperitoneum | Pneumo-peritoneum Test | PASS |
| Articulation system strength | Shape Forming Verification Test | PASS |
| Actuation system strength | Crimp Strength Test | PASS |
| Instrument to withstand repeated | ||
| uses | Repeated Simulated Use Test | PASS |
| Instrument to meet customer | ||
| needs for grasping, dissecting, | ||
| and providing sufficient rigidity to | ||
| the user in the actuated state | Customer Evaluation Report | PASS |
The results of the non-clinical tests demonstrate the Diamond-Flex® Graspers meet or exceed all performance requirements, and are substantially equivalent to the predicate devices.
00041
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MAY - 6 2011
CareFusion 2200, Inc. % Ms. Jane Weber Regulatory Affairs Manager 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K110257
Trade/Device Name: Diamond-Flex® Graspers and Dissectors Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: April 18, 2011 Received: April 20, 2011
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
4
Page 2 - Ms. Jane Weber
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Aty B. R
for
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Premarket Notification Diamond-Flex® Graspers
KII0257 pg 1 of 1
Image /page/5/Picture/2 description: The image contains the logo for CareFusion. The logo consists of a stylized image on the left and the word "CareFusion" on the right. The stylized image appears to be a circular shape with intricate, abstract designs within it.
1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: 847.473.7774
Indications for Use
510(k) Number (if known):
Device Name: Diamond-Flex® Graspers and Dissectors
Indications for Use:
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.
Prescription Use _ X or Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
N.H.R. Oden Forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K110257
CareFusion Confidential