(45 days)
No
The 510(k) summary describes reusable surgical packs containing gowns, drapes, and towels. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The description focuses on the physical components and intended use in surgical procedures.
No.
The device provides sterile gowns, drapes, and towels for use during surgical procedures to protect against contamination, and surgical towels for absorption. It does not treat or cure a disease or condition.
No
Explanation: The device, Presbyterian Linen Services Surgical Packs, provides sterile gowns, drapes, and towels for use in surgical procedures to protect from contamination and absorb fluids. It is not used to diagnose a medical condition or disease.
No
The device description clearly states it is composed of reusable gowns, drapes, and toweling, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical 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 Presbyterian Linen Services Surgical Packs are used during surgical procedures to provide sterile barriers (gowns, drapes, towels) to prevent the transfer of contamination. They are physical barriers used on or around the patient and personnel, not for testing bodily specimens.
- Intended Use: The intended use clearly states their purpose is to "protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination." This is a barrier function, not a diagnostic testing function.
Therefore, based on the provided information, the Presbyterian Linen Services Surgical Packs are not IVDs. They are surgical accessories used for infection control and fluid management during procedures.
N/A
Intended Use / Indications for Use
Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.
Product codes
Not Found
Device Description
Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer's specifications for that procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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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
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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)
Reference Device(s)
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)
Not Found
§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Presbyterian Healthcare System
Presbyterian Hospital 200 Hawthorne Lane Post Office Box 33549 Charlotte, NC 28233-3549 (704) 384-4000 http://www.presbyterian.org
SUMMARY OF SAFETY AND EFFECTIVENESS
January 21, 1997
K970286
Regulatory Information 1.
Device Name: Surgical Procedure Packs Presbyterian Linen Surgical Procedure Packs Proprietary: Surgical Packs Common : Classification: Surgical Procedure Packs
Submitted on behalf of Presbyterian Linen by: 2.
Medline Industries, Inc. One Medline Place Mundelein, IL 60060 (847) 949-2639 Phone: (847) 949-2643 Fax: Lara N. Simmons Contact Person: See Attached Letter of Authorization
Presbyterian Linen Services' Surgical Packs are substantially equivalent to the following:
- K932522 AMSCO Sterile Recoveries Surgical Packs 1.
- K935199 Associated Hospital Services, Inc. Surgical Packs 2.
- K930700 Medline's Repeat Performance Surgical Pack System 3.
Presbyterian Linen's Surgical Packs are virtually identical to the predicate devices listed above. The gowns, towels and drapes are of the same material and construction. There are no technological differences between the Presbyterian Linen packs and the predicate devices.
Device Description
Presbyterian Linen Services Surgical Packs are packs composed of reusable gowns, drapes, and toweling, the specifics of which are tailored to the customer's specifications for that procedure.
Intended Use:
Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.
The Whole Approach To Health.
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