(60 days)
Davol Gravity Drain
Not Found
No
The device description and intended use describe a simple passive wound drain with no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The performance studies are standard biocompatibility tests, not related to algorithmic performance.
Yes
The device is described as a "Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site," which indicates its use in aiding the healing process after surgery, falling under the definition of a therapeutic device.
No
Explanation: The device is described as a "Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site." Its function is passive drainage, not to diagnose a condition or disease.
No
The device description clearly states it is a "Passive Wound Drain" made of "Flat Silicone Drain" and mentions physical characteristics like dimensions, inner diameter teeth, and a radiopaque stripe. It also describes biocompatibility testing, which is relevant to physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site." This describes a physical process performed on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Passive Wound Drain." This is a physical device used for drainage, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVD devices are used to perform tests in vitro (outside the body) on samples to provide information about a person's health. This device is used in vivo (inside the body) for a physical drainage function.
N/A
Intended Use / Indications for Use
Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.
Product codes
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Device Description
Passive Wound Drain
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue operative site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Biocompatibility Testing:
- Rabbit Pyrogen Test: non-pyrogenic
- Hemolysis-Rabbit Blood: non-hemolytic at 2.02% Hemolysis
- Salmonella typhimurium Reverse Mutation Assay: non-mutagenic
- Kligman Maximization Study (Cottonseed Oil Extract): Grade I - weak allergenic potential (not considered significant)
- Kilgman Maximization Study (Sodium Chloride Extract): Grade I - weak allergenic potential (not considered significant)
- USP CLASS VI: Satisfied the requirements of USP XXII Biological Test for Plastics, Class VI-121°C
- ELUTION TEST: non-cytotoxic
- USP MUSCLE IMPLANTATION STUDY IN RABBITS WITH HISTOPATHOLOGY (90 Days): met USP requirements
Key Metrics
Not Found
Predicate Device(s)
Davol Gravity Drain
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4680 Nonpowered, single patient, portable suction apparatus.
(a)
Identification. A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.(b)
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 § 878.9.
0
Image /page/0/Picture/1 description: The image shows the logo for SIL-MED. The logo consists of a stylized letter "S" formed by two rounded rectangles stacked on top of each other, with a small circle in the upper left corner. The words "SIL-MED" are printed below the symbol in a bold, sans-serif font, and the registered trademark symbol is present next to both the symbol and the company name.
Sil-Med Corporation
700 WARNER BLVD. TAUNTON, MA 02780 (508) 823-7701 FAX: (508) 823-1438
MAR 1 1 1996
510 (k) Summary
Company: Sil-Med Corporation 700 Warner Boulevard Taunton, MA 02780
Telephone: Fax:
(508) 823-7701 (508) 823-1438
Contact Person: Karen K. Sylvia QA/QC Manager
| Trade Name: | Penrose Drain |
|---|---|
| Common Name: | Flat Silicone Drain |
| Classification Name: | Apparatice, Single Patient Use, Portable, Non-Powered (878.4680) |
| Description: | Passive Wound Drain |
| Predicate Device: | Davol Gravity Drain |
| Intended Use: | Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site. |
Biocompatability Testing:
| Test | Results |
|---|---|
| Rabbit Pyrogen Test | non-pyrogenic |
| Hemolysis-Rabbit Blood | non-hemolytic at 2.02% Hemolysis |
| Salmonella typhimurium REVERSE | |
| Mutation ASSAY | non-mutagenic |
| Kligman Maximization Study | |
| (Cottonseed Oil Extract) | Grade I - weak allergenic potential (not |
| considered significant) | |
| Kilgman Maximization Study (Sodium | |
| Chloride Extract) | Grade I - weak allergenic potential (not |
| considered significant) | |
| USP CLASS VI | Satisfied the requirements of USP XXII Biological |
| Test for Plastics, Class VI-121°C | |
| ELUTION TEST | non-cytotoxic |
| USP MUSCLE IMPLANTATION | |
| STUDY IN RABBITS WITH | |
| HISTOPATHOLOGY (90 Days) | met USP requirements |
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K960099 ಕಿಳಿದ
Sil-Med Corporation 510 (k) Summary Penrose Drain
page 2
Sil-Med Corporation's Penrose Drain is dimensionally equivalent to the Davol Gravity Drain, except Davol offers both 12" and 18"; Sil-Med Corporation offers 18" only. Both have inner diameter teeth to prevent the drain from collapsing. Both devices have a Radiopaque stripe. Davol Gravity Drains are sold sterile and non sterile. Sil-Med Penrose Drains are sold sterile only. The intended use of both drains is equivalent.
Date: 1/10/96