(294 days)
Not Found
No
The summary describes a mechanical and electrosurgical instrument with no mention of AI or ML capabilities.
No.
The device is described as a surgical instrument used for cutting, dissecting, and coagulating tissue during procedures, which are interventional actions rather than therapeutic ones aimed at treating a disease or disorder.
No
This device is a surgical instrument designed for cutting, dissecting, and coagulating tissue, not for diagnosing medical conditions.
No
The device is a physical surgical instrument with disposable and reusable hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation" and to "mechanically cut tissue and suture." This describes a surgical instrument used on the patient's body, not a device used to test samples from the body (which is the definition of an IVD).
- Device Description: The description details a surgical instrument with scissors tips and a handle, designed to cut, dissect, and coagulate tissue during surgery. This aligns with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.
Product codes
GEI, HET
Device Description
The Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument that is intended to produce a specific tissue effect such as dissecting, cutting, or coagulation by directing a variety of electrical high frequency currents through to a target tissue without causing damage to non-target tissue. The scissors are designed to fit through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state.
The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook.
The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Electrosurgical Safety and Performance Tests: All three scissors tips designs passed the 1kVp High Frequency Test and the Mains Frequency Test.
Cut and Coagulation Performance Tests: All three scissors tip designs, as appropriate, successfully cut a variety of material (tissue, suture, and gastric band). Scissors successfully dissect during electrosurgical cutting and coagulation.
Biocompatibility Tests: Scissors materials are toxicologically and chemically acceptable for the indicated use.
Cleaning and Sterilization Validations: Validations confirmed a sterility assurance level of 10-6.
N/A - No clinical tests were conducted for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K030890 — Snowden-Pencer Switchblade Scissors, K931340 — V. Mueller Laparoscopic Scissors
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.
0
Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon with a stylized letter "C" inside, followed by the word "CareFusion" in a bold, sans-serif font. The icon is to the left of the text, and the overall design is simple and professional.
SEP 7 2012
510(k) SUMMARY
The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.
| SUBMITTER INFORMATION | |
|---|---|
| Name | CareFusion 2200 Inc. |
| Address | 1500 Waukegan Road, McGaw Park, IL 60085 |
| USA | |
| Phone Number | 847-473-7334 |
| Fax Number | 847-473-7790 |
| Establishment Registration Number | 1423507 |
| Name of Contact Person | Kate Fuller |
| Date Prepared | June 22, 2012 |
| NAME OF DEVICE | |
| Trade or Proprietary Name | Snowden-Pencer™ Laparoscopic Ergonomic |
| Reposable Scissors | |
| Common or Usual Name | Laparoscopic Scissors |
| Classification Name | Electrosurgical, Cutting & Coagulation and |
| Accessories | |
| Classification Panel | 79 |
| Regulation | 878.4800 |
| Product Code | GEI, HET |
| Legally marketed device(s) to which | |
| equivalence is claimed | K030890 — Snowden-Pencer Switchblade |
| Scissors | |
| K931340 — V. Mueller Laparoscopic Scissors | |
| Reason for 510(k) submission | Modify the take-apart feature on the device |
| from a disposable scissors tip to a disposable | |
| shaft and scissors tip. |
Device Description
The Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument that is intended to produce a specific tissue effect such as dissecting, cutting, or coagulation by directing a variety of electrical high frequency currents through to a target tissue without causing damage to non-target tissue. The scissors are designed to fit
1
through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state.
The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook.
The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.
Indications for Use
The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES.
| Switchblade Scissors | V. Mueller | ||
|---|---|---|---|
| Characteristic | Modified Device | K030890 (Predicate) | Laparoscopic Scissors |
| K931340 (Predicate) | |||
| Reposable Device | Reusable | ||
| Handle/Disposable | |||
| Shaft and Scissors Tip | Reusable Handle and | ||
| Shaft/Disposable | |||
| Scissors Tip | Reusable Handle and | ||
| Shaft/Disposable | |||
| Scissors Tip | |||
| Insulation | MT5000 Polyolefin | Polyvinylidene | |
| Fluoride (PVDF) Kynar | Ptfe Teflon | ||
| Blade Designs | Metz, Mini Metz, | ||
| Hook | SAME | SAME | |
| Electrical Rating | 1kVp | 0.5kVp | Not Specified |
| Sterilization – Handle | Pre-Vacuum Steam | ||
| (Wrapped) | SAME | SAME | |
| Sterilization – Tip | EtO | Same | Gamma |
The modified single-use disposable scissors tips and shaft is identical in intended use, principle of operations, and energy type to both the Switchblade Scissors and the V. Mueller® Laparoscopic Scissors. These devices provide delivery of high frequency energy through a connection to a monopolar electrical generator with a universal high frequency monopolar electrosurgical cord.
The modified device, like the predicates, is intended to cut and coagulate and can be used in either an electrified or non electrified state. The modified product has the same basic scissors tip design and is comprised of medical grade stainless steel. The modified device works in the same manner as the predicates, is of similar lengths, and is designed to be used through a 5 mm trocar. The insulation of the modified device has been used in other currently marketed HF surgical devices and has been tested for safety and effectiveness when used with HF monopolar energy.
The modified design has a disposable scissors tip and shaft, simplifying the cleaning of the
2
handle by designing the device so that both the tip and the shaft are disposed after a single use.
All materials used in the construction of the modified device have been tested for safety and effectiveness and are deemed to be substantially equivalent to the predicate devices.
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Modified Device Toct Summani
| Performance Test Summary – Modified Device | ||
|---|---|---|
| Characteristic | Standard/Test/FDA Guidance | Testing Conclusions |
| Electrosurgical Safety and | ||
| Performance Tests | IEC 60601-1, 60601-2, 60601-2- | |
| 2, 60601-2-18 | All three scissors tips designs | |
| passed the 1kVp High | ||
| Frequency Test and the Mains | ||
| Frequency Test. | ||
| Cut and Coagulation | ||
| Performance Tests | Bench top and design | |
| validation testing | All three scissors tip designs, as | |
| appropriate, successfully cut a | ||
| variety of material (tissue, | ||
| suture, and gastric band). | ||
| Scissors successfully dissect | ||
| during electrosurgical cutting | ||
| and coagulation. | ||
| Biocompatibility Tests | ISO 10993-1, 10993-5 and | |
| 10993-10 | Scissors materials are | |
| toxicologically and chemically | ||
| acceptable for the indicated | ||
| use. | ||
| Cleaning and Sterilization | ||
| Validations | ISO 11135, ISO 11138-1, ISO | |
| 11737-1, ISO 11737-2, | ||
| ISO17664, ISO17665-1, TIR12, | ||
| ST79, ST81 | Validations confirmed a sterility | |
| assurance level of 10-6. | ||
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL | ||
| EQUIVALENCE AND/OR CLINICAL INFORMATION | ||
| N/A - No clinical tests were conducted for this submission. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 7 2012
Carefusion 2200, Incorporated % Ms. Katherine M. Fuller Manager, Regulatory Affairs 1500 Waukegan Road McGaw Park, Illinois 60085
Re: K113407
Trade/Device Name: Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HET Dated: August 24, 2012 Received: August 27, 2012
Dear Ms. Fuller:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 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
4
Page 2 -- Ms. Kate Fuller
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1500 Waukegan Road McGaw Park, IL 600085 847-473-7334 tel.
carefusion.com
Image /page/5/Picture/2 description: The image shows the logo for CareFusion. The logo consists of a black circle with a white shield inside on the left, and the word "CareFusion" in black on the right. The shield inside the circle has a stylized design with a pointed top and curved sides.
510(k) Number: K113407
Device Name:
Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors
Indications for Use:
The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.
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 IF NEEDED)
Concurrance of CDRH, Office of Device Evaluation (ODE)
(Division Sign-C (Division Sign-On)
Division of Surgical, Orthopedic.
Division of Surgices Division of Startive Devices
510(k) Number K113407