(53 days)
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No
The document describes reprocessed surgical scissor tips and their intended use and testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The focus is on the physical characteristics and reprocessing of the device.
No
The device is described as a surgical tool used for cutting, preparing, mobilizing, and coagulating tissue during procedures, rather than for treating or preventing a disease or condition.
No
The device is described as surgical reprocessed scissor tips intended for cutting, preparation, mobilization, and coagulation of tissue during surgical procedures, not for diagnosing conditions.
No
The device described is a physical medical device (reprocessed scissor tips) used in surgical procedures, not a software-only device. The submission focuses on the reprocessing and functional testing of the physical tips.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. This is a direct surgical intervention on the patient's body.
- Device Description: The description reinforces its use in laparoscopic and open surgical procedures for tissue manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze samples for diagnostic purposes. This device is used inside the body during surgery.
N/A
Intended Use / Indications for Use
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting of tissue.
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation of tissue.
Product codes
NUJ
Device Description
SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into a reusable hand piece and are designed to be used in laparoscopic and open surgical procedures to facilitate coagulation, preparation, mobilization and cutting of tissue. The devices are monopolar and have a cautery connector on the handle or a connector cable. These devices were originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer. Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cautery cable and the generator are not included in the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed scissor tips were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Snowden Pencer Switchblade®, Microline Eversharp®, Aesculap Disposable Scissor Insert, Encision AEM® Scissor Insert
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for SterilMed INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."
FEB 1 2 2008 510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007
For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)
II. SUMMARY AND CERTIFICATION
A. 510(k) Summary
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Joshua Clarin |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 763-488-3483 | |
| Fax: 763-488-3350 | |
| Date Prepared: | December 17, 2007 |
| Trade Name: | Reprocessed Scissor Tips |
| Classification Name: | Electrosurgical Cutting and Coagulation Accessory |
| Classification Number: | Class II, 21 CFR 878.4400 |
| Product Code: | NUJ |
| Predicate
Devices: | The reprocessed scissor tips are substantially equivalent to Snowden Pencer Switchblade®,
Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insert
sterile electrosurgical scissors. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into a
reusable hand piece and are designed to be used in laparoscopic and open surgical procedures
to facilitate coagulation, preparation, mobilization and cutting of tissue. The devices are
monopolar and have a cautery connector on the handle or a connector cable. These devices
were originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer.
Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cautery
cable and the generator are not included in the scope of this submission. |
| Intended Use: | The reprocessed scissor tips are intended to be used with a reusable hand piece and are
designed for use in minimally invasive and open surgical procedures to facilitate coagulation,
preparation, mobilization, and cutting of tissue. |
| Functional and
Safety Testing: | Representative samples of reprocessed scissor tips were tested to demonstrate appropriate
functional characteristics. Process validation testing was performed to validate the cleaning and
sterilization procedures as well as device packaging. In addition, the manufacturing process
includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed Scissor Tips are substantially equivalent to Snowden Pencer Switchblade®,
Microline Eversharp®, Aesculap Disposable Scissor Insert, and Encision AEM® Scissor Insert
sterile electrosurgical scissors.
This conclusion is based upon the devices' similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2008
SterilMed, Inc. % Mr. Joshua Clarin Senior Regulatory Affairs Specialist 11400 73td Avenue North, Suite 100 Maple Grove, Minnesota 55369
Re: K073613
Trade/Device Name: Reprocessed Scissor Tips Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NUJ Dated: December 20, 2007 Received: December 21, 2007
Dear Mr. Clarin:
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
2
Page 2 – Mr. Joshua Clarin
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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device acre ventures (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistances of at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STERILMED, INC.
Medical Device Reprocessing
Small Equipment & Instrument Repair
510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 20, 2007
For Reprocessed Scissor Tips (Laparoscopic Electric Instrument Accessories)
K0 73613
Indications for Use
510(k) Number (if known):
Device Name: Reprocessed Scissor Tips
Indications for Use:
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation of tissue.
Prescription Use. X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative. and Neurological Devices
510(k) Number L073613
CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.
4
| Manufacturer | Model # | Description |
|---|---|---|
| Aesculap | ||
| (Braun) | PO886 | Hook Scissor Tip, 5mm diameter, |
| 31 cm long | ||
| PO887 | Mini-Metzenbaum Scissor Tip, | |
| 5mm diameter, 31 cm long | ||
| PO888 | Metzenbaum Scissor Tip, 5mm | |
| diameter, 31 cm long | ||
| PO889 | Metzenbaum Scissor Tip, 5mm | |
| diameter, 42 cm long | ||
| Encision | ES0101 | Curved Scissor Tip ½", 35cm long |
| ES0102 | Curved Scissor Tip ¾, 35cm long | |
| ES0110 | Hook Scissor Tip. 35cm long | |
| Microline | 3112 | Scissor Tip Metzenbaum 13.46 mm long |
| 3122 | Scissor Tip Micro 9.4 mm long | |
| 3132 | Scissor Tip Hook 12.7 mm long | |
| 3142 | Scissor Tip Endocut 16.51 mm long | |
| 3152 | Scissor Tip Mini Endocut 11.42 | |
| mm long | ||
| Snowden | ||
| Pencer | 89-5100 | Scissor Tip Curved |
| 89-5200 | Scissor Tip Hook | |
| 89-5300 | Scissor Tip Curved Mini- | |
| Metzenbaum Micro |
:
:
100 - 100 - 100
The following table displays the list of the fifteen (15) Reprocessed Scissors included in this subject K073613 submission: Tips
、
: