(29 days)
Not Found
No
The device description focuses on the mechanical components, materials, and sterilization procedures of arthroscopic blades. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, Arthronet BLACKLINE Arthroscopic Blades, is used for minimally invasive joint surgeries. While it is a surgical tool rather than a standalone treatment, its function is directly involved in performing therapeutic procedures.
No
The device description clearly states its intended use is for minimally invasive joint surgeries, acting as arthroscopic blades for cutting and removing tissue. There is no mention of it being used to diagnose a medical condition.
No
The device description clearly details physical components made of stainless steel and aluminum, intended for surgical use. There is no mention of software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are 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.
- Device Description: The Arthronet BLACKLINE Arthroscopic Blades are described as surgical instruments used during minimally invasive joint surgeries. They are physical blades designed for cutting and removing tissue within the joint.
- Intended Use: The intended use clearly states their application in surgical procedures like synovectomie, subacromial decompression, chondroplastic, and ACL reconstruction. These are all surgical interventions performed on the body.
The device is a surgical tool, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction.
Product codes
HRX
Device Description
The Arthronet BLACKLINE Arthroscopic Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first). This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System. Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joints
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K003203, K955914, K953695, K901735
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
DEC 1 1 2002
48
4. 510(k) Summary
| Product Submitted by: | Arthronet Medical, Inc.
8 Hammond, Suite 108
Irvine, CA 92618
Phone (760) 436-3766
FAX (760) 632-0276 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------|
| Manufactured by: | Arthronet GmbH & Co. KG.
(formerly Imtec Medizintechnik)
Geilenbacher Straße 31
D-51399 Burscheid
Germany |
Introduction
The Arthronet BLACKLINE Arthroscopic Blades are manufactured by Arthronet GmbH & Co. KG (formerly Imtec Medinzentechnik). The Blades are limited-use arthroscopic blade components (intended to be used three times, or until they are damaged/dull - whichever occurs first).
This product consists of either two or three components. The three-component product has an outer blade assembly, an inner blade, and an inner blade hub adapter. The two component product has an outer blade assembly and an inner blade assembly. The blade sets consist of six hub assembly configurations, and has both straight and curved blade configurations. Each configuration, except for the Arthronet 123 series, is designed to fit a specific FDA Cleared Arthroscopic Shaver System.
1
BLACKLINE Blade System
| Arthronet
Blackline Shaver
Blade Series: | Hub Adapter Fits the
following Shaver System: | Materials Used: | Equivalent to: |
|------------------------------------------------|--------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 123 | Arthronet (pending review
and FDA clearance) | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914);
Arthronet, Inc. Series 145/155 Blades
(K003203) |
| 133 | Linvatec, Friatec, Arthrex
Shaver Systems | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914);
Arthronet, Inc. Series 145/155 Blades
(K003203) |
| 153 | Dynonics EP 1 | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914);
Arthronet, Inc. Series 145/155 Blades
(K003203) |
| 163 | Aesculap | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914):
Arthronet, Inc. Series 145/155 Blades
(K003203) |
| 173 | Stryker | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914);
Arthronet, Inc. Series 145/155 Blades
(K003203) |
| 183 | Storz | 304 grade Stainless Steel
and anodized aluminum
for hub | Smith & Nephew Dyonics, Inc. Limited
Reuse Arthroscopic Blades (K955914);
Arthronet, Inc. Series 145/155 Blades
(K003203) |
Arthronet BLACKLINE Arthroscopic Blades are all made from 304 Stainless Steel and the adapter hubs are made from hardened anodized aluminum and stainless steel. These materials are essentially equivalent to those of predicate devices. Configurations and sizes are typical of predicate devices and indicated in catalog labeling.
Arthronet BLACKLINE Arthroscopic Blade assemblies consist of 2 piece and 3 piece blade assemblies, depending upon the shaver system they are used with. The 3 Piece blade consists of a single outer blade/hub assembly within which a two-piece inner blade and hub assembly can be inserted. The inner blade assembly snaps into place within the inner blade hub adapter. The resulting inner blade assembly, in turn, snaps into place within the outer blade assembly. The 2 Piece blade consists of a single blade/hub outer and a single inner blade/hub that are joined together in the identical fashion as the 3 Piece. The distal cutting orifices of the inner and outer blade assemblies align precisely to allow for rotary cutting as the inner blade rotates within the fixed outer blade. These assemblies are designed to facilitate cleaning and autoclave sterilization. Autoclave sterilization parameters are equivalent to predicate products noted and directions for use, cleaning and sterilization are contained in product labeling.
2
The Arthronet BLACKLINE Arthroscopic Blade configurations utilize materials similar to the predicate devices noted in the previous table. All predicate devices noted in this section have the same intended use.
The Arthronet BLACKLINE Arthroscopic Blades have been sold worldwide by Arthronet GmbH & Co. KG and their previous company for eight years and meet international product safety requirements. Submitted product intended for sale in the USA will also bear the CE mark and registration number of the Arthronet GmbH & Co. KG Notified Body and will also meet FDA product labeling requirements. Blades are identified with etched labeling noting the manufacturer and the country of manufacture.
The Arthronet BLACKLINE Arthroscopic Blades are essentially equivalent to the Arthronet Limited Use Arthroscopic Blades (such as the series 145/155 Blades, K003203) and the Smith & Nephew Dyonics Disposable Arthroscopic Blades (K953695) and the Smith & Nephew Dyonics Limited Use Arthroscopic Blades (K955914). Materials used are essentially equivalent and conform to many other surgical instruments.
Arthronet BLACKLINE Arthroscopic Blades are provided in a Non-Sterile condition. Recommended disassembly, cleaning, reassembly and sterilization instructions are identified and included in product labeling. These products are intended to be steam pressure autoclaved at cycle parameters equal to or exceeding 132°C and 2bar pressure for 5 minutes. Cautionary warnings alert the user to thoroughly clean the units prior to sterilization and to remove all debris during the cleaning process. Cleaning and sterilization criteria are recommendations only and are based upon simulated use testing on file with the manufacturer. Labeling clearly indicate that hospitals should use their own validated cleaning and sterilization processes for these types of products.
Arthronet BLACKLINE Arthroscopic Blades are limited use devices. Blades are clearly labeled for use a maximum of three (3) uses. The blade assemblies can be discarded after three uses. Product usage and cautions related to potential damage to the blade assemblies as a result of handling or cleaning are clearly defined in product labeling. All product usage is based upon design data developed during product design, simulated use verification testing, and is also based upon seven years of clinical product experience in the worldwide market.
3
A complete risk analysis has been performed for these products and has been filed with the products' 510(k) submission. There were no identifiable risks associated with the use of this device that can be alleviated by product redesign.
4
ronet Medical, Inc.
The following table demonstrates the substantial equivalence of the Arthroscopic Blades to the following to
| Company: | Device: | Blade
Material | Hub Adapter
Material | Provided
Sterile? | Recommended
Sterilization: | Intended Use: | Reusable? | Design: | 510(k) |
|------------------------------------------------|----------------------------------------------------------|-----------------------------------------|----------------------------------------------------------------------|---------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------|---------|
| Arthronet
GmbH &
CO. KG | Limited Use
Arthroscopic
Blades and Hub
Adapter | Surgical
Grade
Stainless
Steel | Surgical Grade
anodized aluminum | NO | Steam
Autoclave | Joint Surgery
(used with
Arthronet,
Dyonics EP1,
Aesculap, Strkyer,
Storz, Linvatec,
Friatec and
Arthrex external
Shaver systems) | Blades are
Limited Use
(3 times). | Inner and
outer tube
with distal
cutting | Pending |
| Arthronet, Inc. | Limited Use
Arthroscopic
Blades and Hub
Adapter | Surgical
Grade
Stainless
Steel | Surgical Grade
Stainless Steel | NO | Steam
Autoclave | Joint Surgery
(used with Dyonics
PS 3500/EP1,
Linvatec, Concept
and Arthrex
external Shaver
systems) | Blades are
Limited Use
(3 times);
Hubs are
reusable. | Inner and
outer tube
with distal
cutting | K003203 |
| Smith &
Nephew
Dyonics, Inc. | Limited Use
Arthroscopic
Blades | Surgical
Grade
Stainless
Steel | Surgical Grade
Stainless Steel | NO | Steam
Autoclave | Joint Surgery
(used with Dyonics
PS 3500 Shaver
system, or
equivalent) | Limited Use | Inner and
outer tube
with distal
cutting | K955914 |
| Smith &
Nephew
Dyonics, Inc. | Disposable
Arthroscopic
Blades | Surgical
Grade
Stainless
Steel | Surgical Grade
Stainless Steel and
Non-Autoclavable
Plastic | Yes
ETO
sterilized by
Manufacturer | Not
intended to
be
resterilized | Joint Surgery | Single Use | Inner and
outer tube
with distal
cutting | K953695 |
| Micro-Aire
Surgical
Instruments,
Inc. | Arthroscopic
Surgical Blades
(several
models) | Surgical
Grade
Stainless
Steel | Surgical Grade
Stainless Steel and
aluminum | NO | Steam
Autoclave | Joint Surgery | Limited Use | Inner and
outer tube
with distal
cutting | K901735 |
allerialia de article ochile adal o cuente a problemos. Production note note of onlined o por more o por more o por more o por more o por more o por maimente de bara maimane
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus or a family of three figures.
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
Arthronet Medical, Inc. Carolina Schaber 8 Hammond, Suite 108 Irvine, California 92618
Re: K023777
Trade/Device Name: Arthronet Blackline Arthroscopic Blades Regulation Number: 888.1100 Regulation Name: Arthroscope accessories Regulatory Class: Class II Product Code: HRX Dated: November 5, 2002 Received: November 12, 2002
Dear Ms. Schaber:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in
6
Page 2 – Ms. Carolina Schaber
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Special 510(k) Submission Arthronet Medical, Inc Limited-Use Arthronet BLACKLINE Arthroscopic Blade Assemblies
3. Indications for Use
The Arthronet BLACKLINE Arthroscopic Blades are indicated for minimally invasive joint surgeries, including but not limited to synovectomie, subacromial decompression, chondroplastic and ACL reconstruction.
Miriam C. Provoost
Jivision Sign-Off) Division of General, Restorative and Neurological Devices
210(k) Number K023777