(145 days)
Not Found
K041381, K21397
No
The device description and intended use focus on the physical properties and function of an absorbable gelatin sponge for hemostasis and adhesion prevention. There is no mention of AI, ML, image processing, or data-driven performance metrics typically associated with AI/ML devices.
Yes
The device is used to control bleeding and prevent adhesions after surgery, which are therapeutic actions aimed at treating or preventing a medical condition.
No
The device is described as having a "haemostatic effect" and being suitable "for the control of bleeding and as a packing material," which indicates a therapeutic rather than diagnostic function. It is used to "control minimal bleeding" and "prevent adhesions," not to identify or diagnose a condition.
No
The device description clearly states it is a "sterile absorbable gelatin sponge composed of highly purified pH neutral pharmaceutical gelatin of porcine origin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to control bleeding and prevent adhesions during and after surgery. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical sponge implanted in the body, which is consistent with a surgical or implantable device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, Gelita-Spon® Absorbable Gelatin Sponge is a medical device used for surgical purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LYA, KHJ
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. Gelita-Spon 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity, ENT
Indicated Patient Age Range
Not Found
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K041381, K21397
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
§ 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.
0
s1911
Gelita-Spon® Traditional 510(k)
Section 8.0
510(k) Summary of Safety and Effectiveness
Section 8: 510(k) Summary
1
:
Gelita-Spon® Absorbable Gelatin Sponge Summary of Safety and Effectiveness
| Submitter Name: | CuraMedical, BV |
|---|---|
| Submitter Address: | Osdorperweg 590 |
| Amsterdam, NL-1067 SZ, The Netherlands | |
| Contact Person: | Rik Van Beek |
| 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, | |
| Number & | |
| Product Code: | Intranasal Splint (21 CRF 874.4780) LYA; Ear, Nose and Throat |
| Synthetic Polymer Material (21 CRFR 874.3620) KHJ | |
| Predicate Devices: | MeroPack™ Nasal Dressing and Sinus Stent |
| MeroGel ™ Nasal Dressing and Sinus Stent | |
| Device Description | |
| and Statement of | |
| Intended Use | 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. | |
| Gelita-Spon 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. | |
| Summary of | |
| Technological | |
| Characteristics | A table comparing Gelita-Spon to the predicate devices is attached. |
| This comparison demonstrates the substantial equivalence of Gelita- | |
| Spon to the predicate devices. |
2
| Feature | Gelita-Spon® | MeroPack™ Nasal
Dressing and Sinus
Stent | MeroGel™ Nasal
Dressing and Sinus
Stent |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | K041381 | K21397 |
| Manufacturer | CuraMedical, B.V. | Medtronic Xomed, Inc. | Medtronic Xomed, Inc. |
| Classification # &
Product Code | 21 CFR 874.4780 and 21
CFR 874.3620
LYA/KHJ | 21 CFR 874.4780
LYA | 21 CFR 874.3620
KHJ |
| 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/Construc
tion | 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 | Gentle irrigation of | Gentle irrigation of | Gentle irrigation of |
| Removal | residues or natural
resorption | residues or natural
resorption | residues or natural
resorption |
.
3
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.
4
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
5
Section 5.0
Indications for Use Statement
510(k) Number (if known):
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