Gelita-Spon® Absorbable Gelatin Sponge is indicated for use to control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

Device Description

Gelita-Spon® Absorbable Gelatin Sponge is a sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin with haemostatic effect suitable for the control of bleeding and as a packing material. It is able to absorb blood corresponding to about 50 times its own weight and when implanted in vivo, it is completely absorbed within approximately 3 weeks.

AI/ML Overview

The provided document focuses on the 510(k) summary for the Gelita-Spon® Absorbable Gelatin Sponge, establishing its substantial equivalence to predicate devices rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and AI-related aspects cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not specify formal acceptance criteria with numerical targets. Instead, it demonstrates substantial equivalence by comparing the technological characteristics of Gelita-Spon® with two predicate devices (MeroPack™ Nasal Dressing and Sinus Stent and MeroGel™ Nasal Dressing and Sinus Stent).

A comparative table of these characteristics is provided:

Feature	Gelita-Spon®	MeroPack™ Nasal Dressing and Sinus Stent	MeroGel™ Nasal Dressing and Sinus Stent
Intended Use	Post-Op, help control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.	Post-Op, help control minimal bleeding and separate mucosal surfaces/adhesion prevention	Space occupying dressing and/or stent to separate mucosal surfaces, help control minimal bleeding and aid in the natural healing process in the middle and external ear canal
Material/Construction	Porcine-derived gelatin (derived from collagen)	Esterified hyaluronic acid and collagen	Esterified hyaluronic acid
Absorbent Qualities	40 times weight of the device	In excess of 10 times weight of the device	In excess of 10 times weight of the device
Sterility	Gamma radiation	Gamma radiation	Gamma radiation
Resorption Time	Within 21 days	Within 14 days	Within 14 days
Biocompatibility	ISO 10993	ISO 10993	ISO 10993
Method of Action	Hygroscopic, forms gelatinous mass in contact with fluids	Hygroscopic, forms gelatinous mass in contact with fluids	Hygroscopic, forms gelatinous mass in contact with fluids
Method of Removal	Gentle irrigation of residues or natural resorption	Gentle irrigation of residues or natural resorption	Gentle irrigation of residues or natural resorption

The acceptance criteria implicitly are that the device's characteristics are comparable to or better than the predicate devices, particularly for features like absorbent qualities and biocompatibility.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on comparative data with predicate devices and general performance characteristics of the gelatin sponge, not on a specific clinical test set with a defined sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. No expert review or ground truth establishment relevant to a clinical test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is mentioned as there is no specific clinical test set described.

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

This information is not applicable/provided. The device is a physical medical device (absorbable gelatin sponge), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers and AI is irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. The submission relies on the established science and performance characteristics of absorbable gelatin sponges and a comparison to legally marketed predicate devices, rather than a specific ground truth derived from expert consensus, pathology, or outcomes data from a new study for this device.

8. The sample size for the training set

This information is not provided in the document. No "training set" in the context of an algorithm is discussed.

9. How the ground truth for the training set was established

This information is not provided in the document. No "training set" or its ground truth establishment is mentioned.

Summary

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s1911

Gelita-Spon® Traditional 510(k)

Section 8.0

510(k) Summary of Safety and Effectiveness

Section 8: 510(k) Summary

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Gelita-Spon® Absorbable Gelatin Sponge Summary of Safety and Effectiveness

Submitter Name:	CuraMedical, BV
Submitter Address:	Osdorperweg 590Amsterdam, NL-1067 SZ, The Netherlands
Contact Person:	Rik Van BeekQA Manager
Phone Number:	011 31 20 667 5330
Fax Number:	011 31 20 667 5331
Date Prepared:	31 May 2005
Device Trade Name:	Gelita-Spon® Absorbable Gelatin Sponge (Gelita-Spon®)
Classification Name,Number &Product Code:	Intranasal Splint (21 CRF 874.4780) LYA; Ear, Nose and ThroatSynthetic Polymer Material (21 CRFR 874.3620) KHJ
Predicate Devices:	MeroPack™ Nasal Dressing and Sinus StentMeroGel ™ Nasal Dressing and Sinus Stent
Device Descriptionand Statement ofIntended Use	Gelita-Spon® Absorbable Gelatin Sponge is a sterile absorbable gelatinsponge composed of highly purified pH neutral pharmaceutical gelatin ofporcine origin with haemostatic effect suitable for the control of bleedingand as a packing material. It is able to absorb blood corresponding toabout 50 times its own weight and when implanted in vivo, it iscompletely absorbed within approximately 3 weeks.Gelita-Spon is indicated for use to control minimal bleeding bytamponade effect, blood absorption and platelet aggregation followingENT surgery and also to prevent adhesions in the nasal cavity.
Summary ofTechnologicalCharacteristics	A table comparing Gelita-Spon to the predicate devices is attached.This comparison demonstrates the substantial equivalence of Gelita-Spon to the predicate devices.

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Feature	Gelita-Spon®	MeroPack™ NasalDressing and SinusStent	MeroGel™ NasalDressing and SinusStent
510(k) Number		K041381	K21397
Manufacturer	CuraMedical, B.V.	Medtronic Xomed, Inc.	Medtronic Xomed, Inc.
Classification # &Product Code	21 CFR 874.4780 and 21CFR 874.3620LYA/KHJ	21 CFR 874.4780LYA	21 CFR 874.3620KHJ
Intended Use	Post-Op, help controlminimal bleeding bytamponade effect,blood absorption andplatelet aggregationfollowing ENT surgeryand also to preventadhesions in the nasalcavity.	Post-Op, help controlminimal bleeding andseparate mucosalsurfaces/adhesionprevention	Space occupyingdressing and/or stentto separate mucosalsurfaces, help controlminimal bleeding andaid in the naturalhealing process inthe middle andexternal ear canal
Material/Construction	Porcine-derived gelatin(derived from collagen)	Esterified hyaluronicacid and collagen	Esterified hyaluronicacid
AbsorbentQualities	40 times weight of thedevice	In excess of 10 timesweight of the device	In excess of 10 timesweight of the device
Sterility	Gamma radiation	Gamma radiation	Gamma radiation
Resorption Time	Within 21 days	Within 14 days	Within 14 days
Biocompatibility	ISO 10993	ISO 10993	ISO 10993
Method of Action	Hygroscopic, formsgelatinous mass incontact with fluids	Hygroscopic, formsgelatinous mass incontact with fluids	Hygroscopic, formsgelatinous mass incontact with fluids
Method of	Gentle irrigation of	Gentle irrigation of	Gentle irrigation of
Removal	residues or naturalresorption	residues or naturalresorption	residues or naturalresorption

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines.

Public Health Service

DEC 6 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CuraMedical, BV c/o William Greenrose President Qserve America, Inc. 220 River Road Claremont, NH 03743

Re: K051911

Trade/Device Name: Gelita-Spon® Absorbable Gelatin Sponge (Gelita-Spon) Regulation Number: 21 CFR 874.3620 Regulation Name: Ear, nose and throat synthetic polymer material Regulatory Class: Class II Product Code: KHJ, LYA Dated: November 3, 2005 Received: November 8, 2005

Dear Mr. Greenrose:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - William Greenrose

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legaliy marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

David M. Whipple

Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5.0

Indications for Use Statement

510(k) Number (if known):

K054911

Device Name: Indications for Use: Gelita-Spon® Absorbable Gelatin Sponge (Gelita-Spon®)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH; Office of Device Evaluation (ODE)

× Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Karenh. Baker

Nose and Throat D

510(k) Number

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.