(91 days)
Not Found
Not Found
No
The summary describes a mechanical surgical stapler and does not mention any AI or ML components or functionalities.
No
The device is a surgical stapler used for approximating tissue and affixing surgical mesh, which assists in surgical procedures rather than directly treating or curing a medical condition.
No
The device description states its function is to approximate tissue and affix surgical mesh, which are surgical actions, not diagnostic ones. There is no mention of analysis, measurement, or diagnosis.
No
The device description clearly describes a physical surgical stapler with mechanical components (reloadable cartridge, shaft/handle portion, staples), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for approximating tissue and affixing surgical mesh during surgical procedures (minimally invasive or open). This is a direct surgical intervention on the patient's body.
- Device Description: The device is a surgical stapler, designed to physically manipulate and join tissues.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) 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 body, while this device is used to perform a surgical procedure directly on the body.
N/A
Intended Use / Indications for Use
The New Device is intended for the same use as the Predicate Devices. All of these devices are intended for use in either minimally invasive or open surgical procedures. All of these devices are used for approximating tissue and affixing surgical mesh to tissue.
Product codes
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Device Description
The Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with Reload Unit is a sterile, single patient-use multi-fire stapler that articulates on a rotating shaft and is intended for use in minimally invasive or open surgical procedures. The device is composed of two primary sections: (1) a reloadable cartridge and (2) a shaft/handle portion. The ETHICON Endoscopic Multifeed Stapler is a sterile, single patient-use multi-fire stapler which provides titanium or stainless steel staples.
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)
Pre-clinical and Clinical data were deemed unnecessary for support of this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AutoSuture® ENDO Universal 65° Disposable Surgical Stapler
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4740 Surgical stapler.
(a) Surgical stapler for external use.
(1)
Identification. A surgical stapler for external use is a specialized prescription device used to deliver compatible staples to skin during surgery.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.(b) Surgical stapler for internal use.
(1)
Identification. A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Performance testing must demonstrate that the stapler, when used with compatible staples, performs as intended under anticipated conditions of use. Performance testing must include the following:
(A) Evaluation of staple formation characteristics in the maximum and minimum tissue thicknesses for each staple type;
(B) For manual staplers only, measurement of the worst-case deployment pressures on stapler firing force;
(C) Measurement of staple line strength;
(D) Confirmation of staple line integrity; and
(E) In vivo confirmation of staple line hemostasis.
(ii) For powered staplers only, appropriate analysis/testing must demonstrate the electromagnetic compatibility and electrical, thermal, and mechanical safety of the device.
(iii) For powered staplers only, appropriate software verification, validation, and hazard analysis must be performed.
(iv) Human factors testing must demonstrate that the clinician can correctly select and safely use the device, as identified in the labeling, based on reading the directions for use.
(v) The elements of the device that may contact the patient must be demonstrated to be biocompatible.
(vi) Performance data must demonstrate the sterility of the device.
(vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization protocol in the labeling.
(viii) Performance data must support the shelf life of the device by demonstrating continued device functionality, sterility, and package integrity over the identified shelf life.
(ix) Labeling of the device must include the following:
(A) Unless data demonstrates the safety of doing so, contraindications must be identified regarding use of the device on tissues for which the risk of stapling outweighs any reasonably foreseeable benefit due to known complications, including the stapling of tissues that are necrotic, friable, or have altered integrity.
(B) Unless available information demonstrates that the specific warnings do not apply, the labeling must provide appropriate warnings regarding how to avoid known hazards associated with device use including:
(
1 ) Avoidance of use of the stapler to staple tissue outside of the labeled limits for maximum and minimum tissue thickness;(
2 ) Avoidance of obstructions to the creation of the staple line and the unintended stapling of other anatomic structures;(
3 ) Avoidance of clamping and unclamping of delicate tissue structures to prevent tissue damage;(
4 ) Avoidance of use of the stapler on the aorta;(
5 ) Establishing proximal control of blood vessels prior to stapling where practical and methods of blood vessel control in the event of stapler failure;(
6 ) Ensuring stapler compatibility with staples; and(
7 ) Risks specifically associated with the crossing of staple lines.(C) Specific user instructions for proper device use including measures associated with the prevention of device malfunction, and evaluation of the appropriateness of the target tissue for stapling.
(D) List of staples with which the stapler has been demonstrated to be compatible.
(E) Identification of key performance parameters and technical characteristics of the stapler and the compatible staples needed for safe use of the device.
(F) Information regarding tissues on which the stapler is intended to be used.
(G) Identification of safety mechanisms of the stapler.
(H) Validated methods and instructions for reprocessing of any reusable device components.
(I) An expiration date/shelf life.
(x) Package labels must include critical information and technical characteristics necessary for proper device selection.
0
K96258
Appendices
510(k) Summary of Safety and Effectiveness (App. A)
{
| Statement | Information supporting claims of substantial equivalence, as defined under the
Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is
summarized below. For the convenience of the Reviewer, this summary is
formatted in accordance with the Agency's final rule "...510(k) Statements..."
(21 CFR §807) and can be used to provide a substantial equivalence summary
to anyone requesting it from the Agency. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Names of Devices with New Labeling:
Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with
Swiveling Cartridge Tip Ethicon Endo-Surgery Endoscopic Multifeed Stapler Predicate Device Names: AutoSuture® ENDO Universal 65° Disposable Surgical Stapler |
| Device
description | The Ethicon Endo-Surgery Endoscopic Articulating Multifeed Stapler with
Reload Unit is a sterile, single patient-use multi-fire stapler that articulates on a
rotating shaft and is intended for use in minimally invasive or open surgical
procedures. The device is composed of two primary sections: (1) a reloadable
cartridge and (2) a shaft/handle portion. The ETHICON Endoscopic
Multifeed Stapler is a sterile, single patient-use multi-fire stapler which
provides titanium or stainless steel staples. |
| Intended use | The New Device is intended for the same use as the Predicate Devices. All of
these devices are intended for use in either minimally invasive or open surgical
procedures. |
| Indications
statement | The indications statement for the New Device and the Predicate Devices is the
same. All of these devices are used for approximating tissue and affixing
surgical mesh to tissue. |
| Technological
characteristics | There are no new technological characteristics in the New Device. All of these
devices are manually actuated surgical staplers. There are no new materials
used in the design of the New Device. |
| Performance
data | Pre-clinical and Clinical data were deemed unnecessary for support of this
premarket notification. |
| Conclusion | Based on the 510(k) "Substantial Equivalence" decision-making process and
the information provided herein, we conclude that the New Device is
substantially equivalent to the Predicate Device under the Federal Food, Drug
and Cosmetic Act. |
| Contact | Melissa Walker, Ethicon Endo-Surgery, Inc., 4545 Creek Road, Cincinnati,
Ohio 45242. |
| Date | June 10, 1996 |
Continued on next page
1
510(k) Summary of Safety and Effectiveness (App. A), Continued
イ
{