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K Number
K962133
Device Name
EXPANDACELL INJECTO-PAK
Manufacturer
SHIPPERT MEDICAL TECHNOLOGIES CORP.
Date Cleared
1996-08-01

(59 days)

Product Code
EMX
Regulation Number
874.4100
Type
Traditional
Panel
Ear Nose & Throat
Reference & Predicate Devices
K954845,K960228
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Not Found

Device Description

Expandacell Injecto-Pak Foam Pack

AI/ML Overview

The provided "SMDA SUMMA for Safety and Effectiveness" document does not contain information about acceptance criteria, device performance metrics, or any studies, human or otherwise, that would typically be associated with modern medical device clearances, especially for devices involving AI or diagnostic performance. Instead, it is a summary for a 510(k) submission for a physical medical device (Expandacell Injecto-Pak Foam Pack) from 1994, focusing on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information. The document explicitly states:

  • "This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device."
  • "The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate devices stated."

This indicates that the submission is based on the substantial equivalence of device characteristics and intended use to previously cleared devices, rather than a new study demonstrating performance against specific acceptance criteria.

To address each point in your request:

  1. A table of acceptance criteria and the reported device performance: Not applicable. No performance metrics or acceptance criteria are listed.
  2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document predates widespread AI in medical devices and does not describe such a study.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

{0}------------------------------------------------

SMDA SUMMA for Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the written requirements of SMDA 1990 and 21 CFR 807.92

SAFETY AND EFFECTIVENESS OF EXPANDACELL INJECTO-PAK FOAM PACK FOR ADMINISTRATION OF LIQUID MEDICATION AND HYDRATING FOR THE SINUS

No specific medication is mentioned. The physician will choose medication indicated.

This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The Expandacell Sinus Pack K935724/S1, Expandacell Injecto-Pak, K954845, and the Expandacell Injecto-Pak K960228 have a proven track record that establishes this product line as safe to the post-operative nasal or post-operative sinus surgery patient. The modification of adapting this product for use in the sinus does not change the safety or effectiveness of this device.

The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate devices stated.

The Toxic Shock issue has been addressed in previous 510(k) applications and this product line addresses this issue on its instructions. Appropriate warning and directions are given for symptoms and appropriate care.

Sarah Maxwell Lake

Signature

May 22, 1994
Date

filename: 510KINJS.doc

§ 874.4100 Epistaxis balloon.

(a)
Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.(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 § 874.9.