GELITA-SPON

K051911 · Curamedical, BV · KHJ · Dec 6, 2005 · Ear, Nose, Throat

Device Facts

• Record ID: K051911
• Device Name: GELITA-SPON
• Applicant: Curamedical, BV
• Product Code: KHJ · Ear, Nose, Throat
• Decision Date: Dec 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3620
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Gelita-Spon® is a sterile, absorbable gelatin sponge of porcine origin; used as a haemostatic agent and packing material in ENT surgery. Device functions via tamponade effect, blood absorption, and platelet aggregation; absorbs blood up to 50 times its weight. Implanted in vivo, it is completely absorbed within approximately 3 weeks. Used by surgeons in clinical settings to manage post-operative bleeding and prevent mucosal adhesions. Device is hygroscopic, forming a gelatinous mass upon contact with fluids; removed via gentle irrigation or natural resorption.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing per ISO 10993, absorption capacity (up to 50 times weight), and resorption time (within 21 days). No clinical data provided.

Technological Characteristics

Material: Porcine-derived gelatin (collagen). Form: Absorbable sponge. Principle: Hygroscopic, forms gelatinous mass. Sterilization: Gamma radiation. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for patients undergoing ENT surgery to control minimal bleeding and prevent nasal cavity adhesions.

Regulatory Classification

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.

Predicate Devices

• MeroPack™ Nasal Dressing and Sinus Stent (K041381)
• MeroGel™ Nasal Dressing and Sinus Stent (K21397)

Submission Summary (Full Text)

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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 590<br>Amsterdam, NL-1067 SZ, The Netherlands |
| Contact Person: | Rik Van Beek<br>QA 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,<br>Number &<br>Product Code: | Intranasal Splint (21 CRF 874.4780) LYA; Ear, Nose and Throat<br>Synthetic Polymer Material (21 CRFR 874.3620) KHJ |
| Predicate Devices: | MeroPack™ Nasal Dressing and Sinus Stent<br>MeroGel ™ Nasal Dressing and Sinus Stent |
| Device Description<br>and Statement of<br>Intended Use | Gelita-Spon® Absorbable Gelatin Sponge is a sterile absorbable gelatin<br>sponge composed of highly purified pH neutral pharmaceutical gelatin of<br>porcine origin with haemostatic effect suitable for the control of bleeding<br>and as a packing material. It is able to absorb blood corresponding to<br>about 50 times its own weight and when implanted in vivo, it is<br>completely absorbed within approximately 3 weeks.<br>Gelita-Spon is indicated for use to control minimal bleeding by<br>tamponade effect, blood absorption and platelet aggregation following<br>ENT surgery and also to prevent adhesions in the nasal cavity. |
| Summary of<br>Technological<br>Characteristics | A table comparing Gelita-Spon to the predicate devices is attached.<br>This comparison demonstrates the substantial equivalence of Gelita-<br>Spon to the predicate devices. |

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| Feature | Gelita-Spon® | MeroPack™ Nasal<br>Dressing and Sinus<br>Stent | MeroGel™ Nasal<br>Dressing and Sinus<br>Stent |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K041381 | K21397 |
| Manufacturer | CuraMedical, B.V. | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. |
| Classification # &<br>Product Code | 21 CFR 874.4780 and 21<br>CFR 874.3620<br>LYA/KHJ | 21 CFR 874.4780<br>LYA | 21 CFR 874.3620<br>KHJ |
| Intended Use | Post-Op, help control<br>minimal bleeding by<br>tamponade effect,<br>blood absorption and<br>platelet aggregation<br>following ENT surgery<br>and also to prevent<br>adhesions in the nasal<br>cavity. | Post-Op, help control<br>minimal bleeding and<br>separate mucosal<br>surfaces/adhesion<br>prevention | Space occupying<br>dressing and/or stent<br>to separate mucosal<br>surfaces, help control<br>minimal bleeding and<br>aid in the natural<br>healing process in<br>the middle and<br>external ear canal |
| Material/Construc<br>tion | Porcine-derived gelatin<br>(derived from collagen) | Esterified hyaluronic<br>acid and collagen | Esterified hyaluronic<br>acid |
| Absorbent<br>Qualities | 40 times weight of the<br>device | In excess of 10 times<br>weight of the device | In excess of 10 times<br>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<br>gelatinous mass in<br>contact with fluids | Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids | Hygroscopic, forms<br>gelatinous mass in<br>contact with fluids |
| Method of | Gentle irrigation of | Gentle irrigation of | Gentle irrigation of |
| Removal | residues or natural<br>resorption | residues or natural<br>resorption | residues or natural<br>resorption |

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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 [phone]. 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 [phone] or [phone] 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®)

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.

## (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