(61 days)
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Not Found
No
The summary describes a mechanical skin stapler and does not mention any AI or ML components or functionalities.
No.
The device is a skin stapler intended for routine skin closure, which is a surgical tool, not a therapeutic device designed for treatment or therapy.
No
Explanation: The device is described as a skin stapler used for routine wound closure, which is a therapeutic rather than diagnostic function. It does not mention any role in identifying, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a "sterile, single patient use instrument designed to deliver rectangular, stainless steel staples," indicating it is a physical 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 "routine skin closure in a wide variety of surgical procedures." This is a direct surgical intervention on the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The device is a "Disposable Skin Stapler" designed to "deliver rectangular, stainless steel staples for routine wound closure." This describes a surgical tool for physically closing wounds.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is clearly a surgical instrument used for a physical procedure on the patient's body.
N/A
Intended Use / Indications for Use
The New Device is intended for the same use as the Predicate Device. It is intended to be used for routine skin closure. The indications statement for the New Device and the Predicate Device is the same. The devices are used for routine skin closure in a wide variety of surgical procedures.
Product codes
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Device Description
The PROXIMATE® Disposable Skin Stapler is a sterile, single patient use instrument designed to deliver rectangular, stainless steel staples for routine wound closure.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A pre-clinical study was conducted to evaluate the cosmetic appearance and perceived ease of extraction of skin staples coated with calcium stearate applied to the PROXIMATE® Disposable Skin Staplers. All results were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
MAR | | |997
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. |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
description | The PROXIMATE® Disposable Skin Stapler is a sterile, single patient use
instrument designed to deliver rectangular, stainless steel staples for routine wound
closure. |
| Intended use | The New Device is intended for the same use as the Predicate Device. It is intended to
be used for routine skin closure. |
| Indications
statement | The indications statement for the New Device and the Predicate Device is the same.
The devices are used for routine skin closure in a wide variety of surgical procedures. |
| Technological
characteristics | There are no new technological characteristics in the New Device. |
| Performance
data | A pre-clinical study was conducted to evaluate the cosmetic appearance and perceived
ease of extraction of skin staples coated with calcium stearate applied to the
PROXIMATE® Disposable Skin Staplers. All results were acceptable. |
| 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 | Lorri Chavez, Ethicon Endo-Surgery, Inc., 4545 Creek Road, Cincinnati, Ohio 45242 |
| Date | January 8, 1996 |