Gelita-Spon® Absorbable Gelatin Sponge, USP 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 USP 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. Gelita-Spon is identical to the predicate device in components, composition, specification, manufacture and packaging. Additional testing to confirm compliance with all test criteria in the USP, specifically including certain biocompatibility tests the methodology of which are slightly different from ISO 10993, was performed following FDA guidance in order to append 'USP' to the product name.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called Gelita-Spon® Absorbable Gelatin Sponge, USP. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and device performance metrics.

Therefore, many of the requested elements regarding acceptance criteria, study details, and performance metrics (especially those related to AI or comparative effectiveness studies) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the device's characteristics and the comparison to its predicate device. This submission is for a material, not a diagnostic device, so the data requested regarding ground truth, expert opinions, and AI performance is not relevant.

Here's the information that can be extracted:

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

The submission does not specify numerical "acceptance criteria" in the traditional sense of a performance study for a diagnostic or therapeutic device with measurable outcomes (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by comparing the new device's characteristics to those of a legally marketed predicate device. The "performance" is considered equivalent if the characteristics are the same or better.

Feature	Predicate Device: Gelita-Spon® Absorbable Gelatin Sponge	New Device: Gelita-Spon® Absorbable Gelatin Sponge, USP	Comparison Outcome ("Performance")
Manufacturer	CuraMedical, B.V.	CuraMedical, B.V.	Identical
Classification # & Product Code	21 CFR 874.4780 and 21 CFR 874.3620 LYA/KHJ	21 CFR 874.4780 and 21 CFR 874.3620 LYA/KHJ	Identical
Intended 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	To control minimal bleeding by tamponade effect, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity	Identical
Material/Construction	Porcine-derived gelatin (derived from collagen)	Porcine-derived gelatin (derived from collagen)	Identical
Absorbent Qualities	40 times weight of the device	40 times weight of the device	Identical
Sterility	Gamma radiation	Gamma radiation	Identical
Resorption Time	Within 21 days	Within 21 days	Identical
Biocompatibility	ISO 10993	ISO 10993 and USP	New device meets an additional standard (USP), indicating improved or at least equivalent safety.
Method of Action	Hygroscopic, forms gelatinous mass in contact with fluids	Hygroscopic, forms gelatinous mass in contact with fluids	Identical
Method of Removal	Gentle irrigation of residues or natural resorption	Gentle irrigation of residues or natural resorption	Identical

The 510(k) summary concludes: "The information discussed above demonstrates that Gelita-Spon® Absorbable Gelatin Sponge, USP is as safe, as effective, and performs as well as or better than the predicate device, Gelita-Spon® Absorbable Gelatin Sponge."

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 510(k) summary. The submission primarily relies on a comparison of technological characteristics and compliance with biocompatibility standards (ISO 10993 and USP), rather than a clinical performance study with a test set of subjects. The additional "biocompatibility tests" performed to append 'USP' are mentioned, but details on the sample size or provenance of these tests are not included.

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)

Not applicable. This is not a diagnostic device or a study involving interpretation by experts. Ground truth in this context refers to the chemical and physical properties of the material.

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

Not applicable, as there is no traditional test set requiring expert adjudication.

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 device is an absorbable gelatin sponge, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm-based device.

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

For the new device, the "ground truth" for its characteristics is established through compliance with recognized standards such as USP (United States Pharmacopeia) and ISO 10993 (Biological evaluation of medical devices), and by chemical and physical testing of the material for properties like absorbent qualities, resorption time, and material composition.

8. The sample size for the training set

Not applicable. This is not a machine learning device; therefore, there is no "training set."

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

Not applicable.

Summary

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

Submitter: CuraMedical, B.V.

510(k) Summary

K060878

APR 2 0 2006

Submitter Name:	CuraMedical, BV
Submitter Address:	Osdorperweg 590 Amsterdam, NL-1067 SZ, The Netherlands
Phone Number:	011 31 20 667 5330
Fax Number:	011 31 20 667 5331
Contact Person:	Rik Van Beek
Date Prepared:	26 March 2006
Device Trade Name:	Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon)
Common Name	Gelatin Sponge
Classification Name, Number & Product Code:	Intranasal Splint (21 CRF 874.4780) LYA; Ear, Nose and Throat Synthetic Polymer Material (21 CRFR 874.3620) KHJ
Predicate Devices:	Gelita-Spon® Absorbable Gelatin Sponge
Device Description and Statement of Intended Use	Gelita-Spon® Absorbable Gelatin Sponge USP 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. Gelita-Spon is identical to the predicate device in components, composition, specification, manufacture and packaging. Additional testing to confirm compliance with all test criteria in the USP, specifically including certain biocompatibility tests the methodology of which are slightly different from ISO 10993, was performed following FDA guidance in order to append 'USP' to the product name. Gelita-Spon® Absorbable Gelatin Sponge USP 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.

Section 3: 510(k) Summary

{1}------------------------------------------------

Submitter:CuraMedical, B.V.	Gelita-Spon® Absorbable Gelatin Sponge, USPPremarket Notification Special 510(k)
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.
Conclusion	The information discussed above demonstrates that Gelita-Spon®Absorbable Gelatin Sponge, USP is as safe, as effective, and performsas well as or better than the predicate device, Gelita-Spon® AbsorbableGelatin Sponge.
Declarations	This summary includes only information that is also covered in the body of the 510(k). This summary does not contain any puffery or unsubstantiated labeling claims. This summary does not contain any raw data, i.e., contains only summary data. This summary does not contain any trade secret or confidential commercial information.

This summary does not contain any patient identification information. 0

{2}------------------------------------------------

Feature	Gelita-Spon® Absorbable GelatinSponge, USP	Gelita-Spon® Absorbable GelatinSponge
510(k) Number		K051911
Manufacturer	CuraMedical, B.V.	CuraMedical, B.V.
Classification # &Product Code	21 CFR 874.4780 and 21 CFR874,3620LYA/KHJ	21 CFR 874.4780 and 21 CFR 874.3620LYA/KHJ
Intended Use	To control minimal bleeding bytamponade effect, bloodabsorption and plateletaggregation following ENTsurgery and also to preventadhesions in the nasal cavity	To control minimal bleeding bytamponade effect, blood absorptionand platelet aggregation followingENT surgery and also to preventadhesions in the nasal cavity
Material/Construction	Porcine-derived gelatin (derivedfrom collagen)	Porcine-derived gelatin (derived fromcollagen)
AbsorbentQualities	40 times weight of the device	40 times weight of the device
Sterility	Gamma radiation	Gamma radiation
Resorption Time	Within 21 days	Within 21 days
Biocompatibility	ISO 10993 and USP	ISO 10993
Method of Action	Hygroscopic, forms gelatinousmass in contact with fluids	Hygroscopic, forms gelatinous massin contact with fluids
Method ofRemoval	Gentle irrigation of residues ornatural resorption	Gentle irrigation of residues or naturalresorption

Summary of Technical Characteristics

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2006

CuraMedical B.V. c/o Mr. William F. Greenrose OServe America, Inc. 220 River Road Claremont, NH 03743

Re: K060787

Trade/Device Name: CuraMedical's Gelita-Spon® Absorbable Gelatin Sponge, USP Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: Class II Product Code: KHJ; LYA Dated: March 29, 2006 Received: March 31, 2006

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.

{4}------------------------------------------------

Page 2 -- Mr. William F. 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 legally 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,

Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Section 2.0

Indications for Use Statement

510(k) Number (if known):

Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon®) Device Name:

Indications for Use:

Gelita-Spon® Absorbable Gelatin Sponge, USP is indicated for use to control minimal Oclita Open® Aboorbades oct, blood absorption and platelet aggregation following ENT surgery and also to prevent adhesions in the nasal cavity.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Karin Bohn

(Division Sign-Off) Division of Ophthalmic E Nose and Throat De

510(k) Number

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

APR 2 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CuraMedical B.V. c/o Mr. William F. Greenrose OServe America, Inc. 220 River Road Claremont, NH 03743

Re: K060878

Trade/Device Name: Gelita-Spon® Absorbable Gelatin Sponge, USP Regulation Number: 21 CFR 874.3620 Regulation Name: ENT Synthetic Polymer Material Regulatory Class: II Product Code: KHJ, LYA Dated: March 29, 2006 Received: March 31, 2006

Dear Mr. Greenrose:

This letter corrects our substantially equivalent letter of April 13, 2006.

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 (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 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 mav 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

Sincerely yours,

M.B. Eychhaus - M.D.

Malvina B. Eydelman, M.D. Division Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Section 2.0

Indications for Use Statement

510(k) Number (if known):

Gelita-Spon® Absorbable Gelatin Sponge, USP (Gelita-Spon®) Device Name:

Indications for Use:

(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)

Keren Parker

on Sian-C sion of Ophthalmic Nose and Throat D

510(k) Number F060878

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.