PENROSE DRAIN MODELS 6001 - 6007

K960099 · Sil-Med Corp. · GCY · Mar 11, 1996 · General, Plastic Surgery

Device Facts

• Record ID: K960099
• Device Name: PENROSE DRAIN MODELS 6001 - 6007
• Applicant: Sil-Med Corp.
• Product Code: GCY · General, Plastic Surgery
• Decision Date: Mar 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4680
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Post-operative passive drainage of serosanguineous fluids away from soft tissue operative site.

Device Story

Passive wound drain; silicone construction; flat design; internal diameter teeth to prevent collapse; radiopaque stripe for visualization. Used post-operatively in clinical settings to facilitate drainage of serosanguineous fluids from soft tissue sites. Operated by clinicians; device functions via gravity-assisted drainage. Sold sterile for single-patient use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed: Rabbit Pyrogen (non-pyrogenic), Hemolysis (non-hemolytic), Salmonella typhimurium reverse mutation assay (non-mutagenic), Kligman Maximization (Grade I), USP Class VI (satisfied), Elution test (non-cytotoxic), and 90-day USP muscle implantation study in rabbits (met requirements).

Technological Characteristics

Material: Silicone. Features: Flat geometry, internal diameter teeth, radiopaque stripe. Dimensions: 18" length. Sterilization: Sterile. Energy source: None (passive).

Indications for Use

Indicated for post-operative patients requiring passive drainage of serosanguineous fluids from soft tissue operative sites.

Regulatory Classification

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.

Predicate Devices

• Davol Gravity Drain

Submission Summary (Full Text)

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K960099
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# SIL-MED

## Sil-Med Corporation

700 WARNER BLVD.
TAUNTON, MA 02780
[phone]
FAX: [phone]

MAR 11 1996

## 510 (k) Summary

Company: Sil-Med Corporation
700 Warner Boulevard
Taunton, MA 02780

Telephone: [phone]
Fax: [phone]

Contact Person: Karen K. Sylvia
QA/QC Manager

Trade Name: Penrose Drain
Common Name: Flat Silicone Drain
Classification Name: Apparative, 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.

### Biocompatibility 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) |
| Kligman 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
2012

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