(606 days)
Not Found
No
The document describes mechanical surgical instruments (staplers and cutters) and their reprocessing. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections explicitly state "Not Found".
Yes
The device is described as "reprocessed reloadable cutters" and "reprocessed reloadable staplers" used for transection, resection, and creation of anastomoses, which are surgical procedures directly involved in treating or mitigating a condition.
No
The device is described as surgical cutters and staplers used for transection, resection, and creation of anastomoses, which are therapeutic actions, not diagnostic.
No
The device description clearly describes physical instruments (cutters and staplers) that deliver staples and divide tissue. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures (transection, resection, creation of anastomoses, approximation of tissues) performed on the patient's body. IVDs are used to examine specimens from the body (like blood, urine, tissue samples) to provide information about a person's health.
- Device Description: The device description details a surgical instrument that delivers staples and divides tissue. This is consistent with a surgical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, the ClearMedical Reprocessed Reloadable Cutters and Staplers are surgical devices, not IVDs.
N/A
Intended Use / Indications for Use
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ, NLL
Device Description
The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastrointestinal, gynecologic, thoracic, pediatric (for cutters); alimentary tract, thoracic (for staplers)
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)
Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip reloadable cutters and staplers perform as intended and are safe and effective.
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.
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.
Not Found
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
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
0
KO33579
JUL 1 ] 2005
510(k) Summary
:
| Submitter: | ClearMedical, Inc.
1776 136th Place NE
Bellevue, WA 98005 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Gene Lim
Ph: (425) 460-2779
Fax: (425) 401-1515 |
| Date: | June 21, 2005 |
| Trade name: | ClearMedical Reprocessed Reloadable Linear Cutters and Staplers |
| Common name: | Reloadable Linear Cutters and Linear Staplers |
| Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Product code: | GCJ - Laparoscope, General & Plastic Surgery |
| Predicate device: | K020779 - Endopath and Proximate Linear Cutters and Staplers |
| Device description: | The Reprocessed Reloadable Cutters deliver two double-staggered
rows of titanium staples while dividing the tissue between the
rows. The reloadable cutters may be reloaded during a single
procedure, up to a maximum number of firings per instrument as
stated in the product insert.
The Reprocessed Reloadable Staplers deliver two double-staggered
rows of titanium staples to approximate internal tissues. The
reloadable cutters may be reloaded during a single procedure, up to
a maximum number of firings per instrument as stated in the
product insert. |
| Intended use: | The ClearMedical Reprocessed Reloadable Cutters are intended
for transection, resection, and creation of anastomoses in
gastrointestinal, gynecologic, thoracic, and pediatric surgery.
The ClearMedical Reprocessed Reloadable Staplers are intended
for the resection of tissues in the alimentary tract and in thoracic
surgery. |
| Technological
characteristics: | Reprocessed reloadable cutters and staplers are used devices that
are cleaned, inspected, tested, packaged, and sterilized for an
additional single patient use. The technological characteristics of
design, material, and functional performance of reprocessed
reloadable cutters and staplers are unchanged and remain
equivalent to the predicate devices. |
| Test data: | Validation of cleaning, performance, packaging, and sterilization
together with biocompatibility testing demonstrate reprocessed clip
reloadable cutters and staplers perform as intended and are safe
and effective. |
| Conclusion: | Based on information provided in this submission, ClearMedical
Reprocessed Reloadable Cutters and Staplers are substantially
equivalent to the identified predicate devices and are safe and
effective for their intended use. |
1
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2005
Clear Medical Incorporated Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005
Re: K033578
K033578
Trade/Device Name: Reprocessed Reloadable Cutters, Staplers, and Appliers Models, Reprocessed Reloadable Cattle, Success, Success, Proximate Linear Staplers TL30, TL60, TX30B, and TX60B Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: May 27, 2005 Received: May 31, 2005
Dear Mr. Kovacs:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 210(x) premained is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced anove and nave decimined the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manced provice andical Device Ameridae, or to commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmetic Act (Act) that to not require approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions o You may, therefore, market the device, subject or as general registration, listing of
general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the Fee merator seat prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into entrols. Existins major regulations affecting your device
it may be subject to such additional controls. Existing may on and it may be subject to such additional controll. "Entroling 21, Parts 800 to 898. In addition, FDA can be found in the Code of Federal Regardies)
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 Please be advised that FDA s issualio of a studential with other requirements of the Act
that FDA has made a determination that your device complies with on your that FDA has made a decisimilation that Jour assess of by other Federal agencies. You must of any Pederal Statutes and regulations daminities on of limited to: registration and issting (21 l comply with all the Act S requirements, mercesses on annufacturing practice requirements as set CPR Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (QD) regalistics (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Mr. Mike Kovacs
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the support of a line of a location to tiel assivelence of your devi This letter will allow you to begin maketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equive and thus, p premarket notification. The IDA Inding of substanted organ 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
rs (11) 11 (11) 11 (11) 111 (11) 176 0115 - Alge - places note the regulat If you desire specific advice for your device on our labeling news note (
contact the Office of Compliance at (240) 276-0115 . Also, please note (2010) . You may obtain contact the Office of Compliance at (240) 270 - 1780, p. Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket noutheadon" (1 on the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free wares/cuppo Manufacturers, International and Consumer 71ssistance as tos vol. Industry/support/index.html.
Sincerely yours,
iriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K033578
$
Device Name: Reprocessed Reloadable Cutters and Staplers
Indications for Use:
Reloadable Cutters
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, The ClearMedical Reprocessed Reloadable Cuttors and a
resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
Reloadable Staplers
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection THE Cleariviculed! Represent and in thoracic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (
) THE SE DO NOT WRITE BELOW (FANSED) IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Device
510(k) Number K033578