(98 days)
Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.
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.
Here's an analysis of the provided information regarding the Diamond-Flex® Graspers, focusing on the acceptance criteria and the study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (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 |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes used for each of the non-clinical tests. It only lists the tests performed and their outcomes ("PASS").
Regarding data provenance, these are non-clinical bench tests and simulations, not human clinical data. Therefore, concepts like country of origin for data or retrospective/prospective study design are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
For the "Customer Evaluation Report" which assesses customer needs for grasping, dissecting, and rigidity, it implies feedback from users (customers). However, the document does not specify the number of "experts" (e.g., surgeons, medical professionals) involved in this evaluation, nor their specific qualifications.
For the other tests (Pneumo-peritoneum, Shape Forming, Crimp Strength, Repeated Simulated Use), the "ground truth" is established by direct measurement against engineering specifications and performance standards. No human experts are explicitly mentioned as establishing ground truth for these objective functional tests.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. Given that most tests are objective engineering performance tests with pass/fail criteria, an adjudication method for conflicting results would likely not be necessary unless specific subjective assessments were performed by multiple individuals.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically for image-based diagnostic or screening devices to assess human reader performance with and without AI assistance. This device is a surgical instrument.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device, the Diamond-Flex® Graspers, is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable. The performance studies conducted evaluate the mechanical and functional integrity of the instrument itself.
7. Type of Ground Truth Used
The ground truth for the tests used in this submission are primarily:
- Engineering Specifications / Performance Standards: For tests like pneumoperitoneum, articulation system strength, actuation system strength, and repeated simulated use, the "ground truth" is defined by pre-established performance metrics and thresholds that the device must meet to be considered functional, safe, and effective.
- Customer Needs/Feedback: For the "Customer Evaluation Report," the ground truth is derived from the stated or perceived needs and expectations of the end-users (customers/surgeons) regarding the device's functional performance in a surgical context.
8. Sample Size for the Training Set
This device is a physical medical instrument developed through engineering and manufacturing processes, not an AI/ML algorithm that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this 510(k) submission.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this type of device. Therefore, the method for establishing ground truth for a training set is not applicable.
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Traditional 510(k) Premarket Notification: Diamond-Flex® Graspers
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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 |
| EstablishmentRegistration Number | 1423507 |
| Name of contact person | Jane Weber |
| Date prepared | 01/19/2011 |
| DEVICE INFORMATION | |
| Trade or proprietaryname | 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 marketeddevice(s) to whichequivalence is claimed | Snowden-Pencer Inc. - Reusable Laparoscopic Instruments - K930667, GCJSurgical 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 handleassembly, an elongate shaft and a 'distal end' which comprises a segmentedflexible portion and the end-effector or jaw pattern. |
| Intended use of thedevice | To grasp and dissect |
| Indications for use | Diamond-Flex® Graspers and Dissectors are designed to transmit graspingforce through delicate working tips in both minimally invasive and opensurgical procedures. |
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Traditional 510(k) Premarket Notification: Diamond-Flex® Graspers
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ﺮ ﺍﻟﻤ
K110257 pg 2 of 3
| SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPAREDTO THE PREDICATE DEVICE | |||
|---|---|---|---|
| Characteristic | Predicate DeviceSnowden-Pencer Inc.ReusableLaparoscopicInstruments - K930667 | Predicate DeviceSurgical InnovationsLimited EndoFlex 5000Endoscopic Forceps -K946239 | New Device |
| Type of Device | Reusable | Reusable | Reusable |
| Materials | Stainless Steel | Stainless SteelNitinol AlloySantopreneNylonPEEKAluminumTungsten Carbide | Stainless SteelNitinol AlloySantopreneNylonPEEKAluminumTungsten Carbide |
| Length | 24cm, 33cm, 45 cm | 33cm, 25.5cm | 34cm, 45cm |
| Articulatingcomponent | None | Segmented flexible portionthat articulates to 40° or 90° | Segmented flexible portionthat articulates to 40° or 90° |
| Articulationmechanism | None | Rotating Actuation knob totighten cable and formshape | Rotating Actuation knob totighten cable and formshape |
| Actuationmechanism | Handle operation causesopening and closing ofend effector | Handle operation causesopening and closing of endeffector | Handle operation causesopening and closing of endeffector |
| Flush port? | Yes | Yes | Yes |
| Sterilizationsleeve? | No | Yes | Yes |
| Requires insertionthrough trocar? | Yes | Yes | Yes |
| Form inserted intotrocar | Not Applicable | Relaxed-unarticulated | Relaxed-unarticulated |
| Grasper patterns | 6 | 10 | 6 (same as K930667) |
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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 repeateduses | Repeated Simulated Use Test | PASS |
| Instrument to meet customerneeds for grasping, dissecting,and providing sufficient rigidity tothe 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
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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
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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
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Traditional 510(k) Premarket Notification Diamond-Flex® Graspers
KII0257 pg 1 of 1
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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
§ 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.