(76 days)
Not Found
No
The device description and intended use clearly describe a mechanical suture needle and punch system, with no mention of software, algorithms, or any technology that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
Explanation: A therapeutic device is designed to treat or alleviate a disease or condition. The Acufex Double Armed Suture Needle is a surgical tool used to pass sutures, which is a procedural step, not a therapy in itself.
No
The device is a surgical tool used to pass sutures for repair, not to identify a disease, condition, or state of health.
No
The device description explicitly states it is a sterile, single-use device manufactured from braided polyester and stainless steel, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Acufex Double Armed Suture Needle is a surgical tool used to physically pass a suture through soft tissue within the body during a surgical procedure. It is a mechanical device used for manipulation and repair, not for analyzing biological samples.
- Intended Use: The intended use clearly states it's for passing sutures through soft tissue for repair in specific surgical procedures (Rotator Cuff and Bankart repairs). This is a surgical intervention, not a diagnostic test.
The information provided about the device's materials, intended use, and surgical application all point to it being a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch. The Acufex Double Armed Suture Needle is indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs.
Product codes
Not Found
Device Description
The Acufex Double Armed Suture Needle is a sterile, single-use device manufactured from braided polyester and stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, Rotator Cuff, Bankart
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Fast Pass Suture Needle (K961853)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
APR 2 1 1997
Section 6: 510(k) Summary of Safety and Effectiveness
970416
ার
প্রকল্পিত
বিশ্বকাপ
This summary of 510(k) safety and effectiveness information is being submitted in 6.1 accordance with the requirements of SMDA 1990 and CFR 807.92. Statement
Smith & Nephew, Inc., Endoscopy Division 6.2 Submitter 130 Forbes Blvd. Mansfield, Ma. 02048
6.3 Susan Finneran Company Clinical/Regulatory Affairs Contact (508) 261-3772
| 6.4 | Proprietary Name: Acufex Double Armed Suture Needle |
|---|---|
| Device Name | Common Name: Suture Needle |
| Classification Name: Nonabsorbable polyester surgical suture |
| 6.5 | |
|---|---|
| Predicate | Fast Pass Suture Needle (K961853) |
| Legally | Smith and Nephew Endoscopy, Inc. |
| Marketed | Mansfield, Ma. |
| Devices |
ર્ભ રહ્યું હતું. સંદર્ભ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ દિવસ
Device The Acufex Double Armed Suture Needle is a sterile, single-use device Description manufactured from braided polyester and stainless steel.
1
6.7
- Intended Use The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch.
6.8
| Device | The Acufex Double Armed Suture Needle is indicated for use in open or |
|---|---|
| Indications | arthroscopic Rotator Cuff and Bankart repairs. |
6.9
| Substantial | The Acufex Double Armed Suture Needle is substantially equivalent to the |
|---|---|
| Equivalence | recently cleared Fast Pass Suture Needle. (K961853) |
Table of Substantial Equivalence
| Product Name | Fast Pass Suture Needle | Acufex Double Armed Suture Needle |
|---|---|---|
| Product Labeling | Sterile (EtO), Single Use | Sterile (EtO), Single Use |
| Materials | polyester/stainless steel | polyester/stainless steel |
| Intended use | Soft tissue fixation | Soft tissue fixation |
| Indications | Arthroscopic and open shoulder lesion repair | Arthroscopic and open shoulder lesion repair |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
Applicant Aus. A. Japp
Date 1/31/97
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