(193 days)
Not Found
No
The device description focuses on the physical properties and construction of instrument protectors made of foam, with no mention of software, algorithms, or any capabilities that would suggest AI/ML.
No
The device's primary purpose is to protect surgical instruments, not to directly treat or diagnose a medical condition in a patient. It is used in the preparation of instrument kits rather than for therapeutic application.
No
The device's primary purpose is to protect surgical instruments during sterilization, storage, and transportation, not to diagnose medical conditions.
No
The device description clearly states the product is made of reticulated polyurethane ester foam and is used for physical protection of surgical instruments, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as protecting surgical instruments during sterilization, storage, and transportation. This is a function related to the handling and preparation of medical devices, not the diagnosis of disease or other conditions.
- Device Description: The description focuses on the physical properties and construction of the foam liners and pouches, designed for padding and protection. There is no mention of any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening
The device's purpose is purely logistical and protective for surgical instruments.
N/A
Intended Use / Indications for Use
The primary purpose of the device is to protect surgical instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.
- The liners are first placed into the empty sterilization tray.
- The instruments are then placed onto the Cygnus liner (or in the pouch) and the trays . are wrapped in CSR wrap using conventional wrapping methods.
- Cygnus tray liners are to be used with steam autoclave sterilization only at . temperature settings ranging between - 121°C to 134 ℃.
- The sterile wrapped kit remains closed until arrival within the sterile prepped . operating room.
- . The liners may continue to be used during the procedure as a sterile field on which to place instruments.
- Upon the completion of the procedure the liners are disposed of in accordance with . applicable medical waste regulations.
Product codes
Not Found
Device Description
The "Cygnus Instrument Protectors" liners and pouches are constructed with reticulated polyurethane ester foam. The material's open cell structure allows for the free flow of air, moisture and heat and is virtually free of The variety of sizes and shapes allows particulate matter. for greater flexibility in padding the instruments. Tray liners are available in precut sheets and rolls. uthe pouches are available in three sizes of single pouches and two sizes of multi pouch rolls. The pouches are formed by heat sealing the edges and seams. Each product is available in individual boxes as well as bulk case The products are shipped and marked as "non packaging. sterile" and "disposable". Each box is marked with a control lot number and universal bar code.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital staff
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)
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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.
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.
Not Found
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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§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
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M. SAFE MEDICAL DEVICES ACT OF 1990 STATEMENT OF SAFETY AND EFFECTIVENESS.
196425 "510(k) Summary" MAY - 6 1997 October 1, 1996 Contact person: Shaun Sweeney (203) 265-9550 phone (203) 265-9961 fax "Cygnus Instrument Protectors" Trade Name : Tray liners, instrument pouches Common Name: Sterilization wrap, pack Classification Name: sterilization wrapper, bag or accessories (per 21 CFR section 880.6850).
Predicate device: Manufacturer Devon Industries, 14569 Titus Street, Panorama City, California 91402 9530 Desoto Drive, Chatsworth, California 91311
Product - Devon Tiprotectors, tray pads and liners 510(k) Number - K771123 General and Plastic Surgery Device Panel Classification - Class II Regulatory Citation - 21 CFR ch 1 (4-1-95)
Product Description
The "Cygnus Instrument Protectors" liners and pouches are constructed with reticulated polyurethane ester foam. The material's open cell structure allows for the free flow of air, moisture and heat and is virtually free of The variety of sizes and shapes allows particulate matter. for greater flexibility in padding the instruments. Tray liners are available in precut sheets and rolls. uthe pouches are available in three sizes of single pouches and two sizes of multi pouch rolls. The pouches are formed by heat sealing the edges and seams. Each product is available in individual boxes as well as bulk case The products are shipped and marked as "non packaging. sterile" and "disposable". Each box is marked with a control lot number and universal bar code.
1
Summery: Intended Use
The primary purpose of the device is to protect surgical instruments during sterilization, storage and transportation to the surgical suite. This product is intended to be used by hospital staff during the preparation of the sterile instrument kits.
- The liners are first placed into the empty sterilization tray. ●
- The instruments are then placed onto the Cygnus liner (or in the pouch) and the trays . are wrapped in CSR wrap using conventional wrapping methods.
- Cygnus tray liners are to be used with steam autoclave sterilization only at . temperature settings ranging between - 121°C to 134 ℃.
- The sterile wrapped kit remains closed until arrival within the sterile prepped . operating room.
- . The liners may continue to be used during the procedure as a sterile field on which to place instruments.
- Upon the completion of the procedure the liners are disposed of in accordance with . applicable medical waste regulations.
Technological Characteristics
The technological characteristics of the Cygrass Instrument Protectors are identical to the predicate devices, as well as a number of other massafisturers producing this type of product. The tensile streagth (30 lbs. psi.), elongution (200%), tour strength (4.0 lbs. psi), density ( 1.9 lb./cu. ft.) and porosity (50Pore per sa. in.) all define this product as being appropriate and consistent with the intended use of the product. ..............................................................................................................................................................................
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